This document provides a review of the Generic Drug User Fee Act (GDUFA) implemented by the US Food and Drug Administration (USFDA). It discusses:
1) The increasing backlog of generic drug applications and inspections that GDUFA aims to address by providing additional funds to the USFDA.
2) The key goals of GDUFA are to ensure safety, efficacy, and access by prioritizing application review, increasing facility inspections, and expediting approval processes.
3) GDUFA fees are paid by generic drug manufacturers and facility owners and are split between application fees and facility fees, with the total revenue expected to be $299 million annually from 2013-
Regulatory requirement of EU, MHRA and TGAHimal Barakoti
The document summarizes regulatory requirements for medicines in the European Union, United Kingdom, Australia, and other countries. The European Medicines Agency regulates medicines for the EU and ensures they are safe, effective and high quality. Medicines must receive market authorization from the EMA or national authorities before sale. The UK's Medicines and Healthcare Products Regulatory Agency regulates clinical trials and product licensing. Australia's Therapeutic Goods Administration ensures medicines available there meet quality, safety and efficacy standards.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
REGULATORY REQUIREMENTS OF EU, MHRA, TGA AND RoW COUNTRIESDhruvi Panchal
The document summarizes the key regulatory requirements for medicines in the European Union (EU), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Australia's Therapeutic Goods Administration (TGA), and countries around the world (RoW). It discusses the roles of the European Medicines Agency (EMA) in the EU for scientific evaluation and marketing authorization of medicines. It also outlines licensing requirements, clinical trials oversight, safety monitoring, and other regulatory processes in the EU, UK, Australia and various other countries.
The document discusses the Investigational Medicinal Product Dossier (IMPD), which contains information about investigational drugs used in clinical trials in the European Union. It provides guidance on the content and legal basis of full and simplified IMPDs. A full IMPD is required for new drugs and includes data on the drug substance, manufacturing, quality controls, preclinical testing, and clinical protocols. A simplified IMPD can be submitted if the drug is already approved or similar information was previously reviewed. The IMPD process aims to standardize information submitted across EU member states for clinical trial authorization.
The document discusses different procedures for obtaining marketing authorization for medicinal products in the European Union. It describes the national authorization procedure which allows approval in a single member state, as well as the centralized procedure which provides an authorization that applies across all EU states. It also outlines the mutual recognition and decentralized procedures, which allow authorization in multiple states via coordination between countries. Key steps, timelines and responsibilities of each process are defined in detail.
The document discusses Chemistry, Manufacturing and Controls (CMC) and its role in pharmaceutical product development and regulatory approval. It provides details on:
- The key functions of CMC including process development, facility inspections, and ensuring compliance.
- CMC content requirements for different application types like NDAs, ANDAs, and INDs.
- How the CMC section evolves over clinical trial phases from laboratory to commercial scale.
- Procedures for developing and submitting post-approval study protocols to regulatory agencies.
cmc [ chemistry manufacturing control ]Akshay Patil
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
Regulatory requirement of EU, MHRA and TGAHimal Barakoti
The document summarizes regulatory requirements for medicines in the European Union, United Kingdom, Australia, and other countries. The European Medicines Agency regulates medicines for the EU and ensures they are safe, effective and high quality. Medicines must receive market authorization from the EMA or national authorities before sale. The UK's Medicines and Healthcare Products Regulatory Agency regulates clinical trials and product licensing. Australia's Therapeutic Goods Administration ensures medicines available there meet quality, safety and efficacy standards.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
REGULATORY REQUIREMENTS OF EU, MHRA, TGA AND RoW COUNTRIESDhruvi Panchal
The document summarizes the key regulatory requirements for medicines in the European Union (EU), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Australia's Therapeutic Goods Administration (TGA), and countries around the world (RoW). It discusses the roles of the European Medicines Agency (EMA) in the EU for scientific evaluation and marketing authorization of medicines. It also outlines licensing requirements, clinical trials oversight, safety monitoring, and other regulatory processes in the EU, UK, Australia and various other countries.
The document discusses the Investigational Medicinal Product Dossier (IMPD), which contains information about investigational drugs used in clinical trials in the European Union. It provides guidance on the content and legal basis of full and simplified IMPDs. A full IMPD is required for new drugs and includes data on the drug substance, manufacturing, quality controls, preclinical testing, and clinical protocols. A simplified IMPD can be submitted if the drug is already approved or similar information was previously reviewed. The IMPD process aims to standardize information submitted across EU member states for clinical trial authorization.
The document discusses different procedures for obtaining marketing authorization for medicinal products in the European Union. It describes the national authorization procedure which allows approval in a single member state, as well as the centralized procedure which provides an authorization that applies across all EU states. It also outlines the mutual recognition and decentralized procedures, which allow authorization in multiple states via coordination between countries. Key steps, timelines and responsibilities of each process are defined in detail.
The document discusses Chemistry, Manufacturing and Controls (CMC) and its role in pharmaceutical product development and regulatory approval. It provides details on:
- The key functions of CMC including process development, facility inspections, and ensuring compliance.
- CMC content requirements for different application types like NDAs, ANDAs, and INDs.
- How the CMC section evolves over clinical trial phases from laboratory to commercial scale.
- Procedures for developing and submitting post-approval study protocols to regulatory agencies.
cmc [ chemistry manufacturing control ]Akshay Patil
This document provides information about Chemistry, Manufacturing and Controls (CMC) regulatory affairs. It discusses the responsibilities of CMC regulatory affairs in providing leadership, strategy and regulatory knowledge to achieve approval of pharmaceutical products. It also summarizes key elements included in CMC regulatory submissions like manufacturing sites, analytical methods and quality testing data. The document further discusses post-approval regulatory requirements including post-approval studies and safety surveillance. It provides examples of combination products and medical device regulations. It introduces the Common Technical Document (CTD) format for registration applications and its electronic version (eCTD). Finally, it summarizes some key ICH guidelines.
The document discusses guidelines for Active Substance Master Files (ASMF) and European Drug Master Files (EDMF) in the European Union. Some key points:
- An ASMF/EDMF contains quality and quality control information for an active pharmaceutical ingredient. It has two parts - an applicant part given to marketing authorization applicants, and a restricted part for regulatory authorities.
- The ASMF procedure can be used for new active substances, existing substances not in pharmacopeias, and pharmacopeial substances. It cannot be used for biological substances.
- Marketing authorization applicants must include specified information from the ASMF in their application dossier and have access to the current active substance manufacturer. ASMF
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
This document discusses post-approval regulatory affairs for drugs and medical devices. It explains that the FDA may require post-approval studies to ensure continued safety and effectiveness of approved products. Sponsors must comply with post-approval requirements or approval can be withdrawn. Post-approval changes are categorized as major, moderate, or minor depending on their potential effect. Major changes generally require prior approval from the FDA, while moderate changes require notification 30 days before distribution. Minor changes are reported annually. The document provides recommendations for common post-approval changes including components, manufacturing sites, processes, specifications, packaging, and labeling.
Investigation of medicinal product dossier (IMPD)Himal Barakoti
The document discusses the Investigational Medicinal Product Dossier (IMPD) which contains detailed information on the quality, manufacture, and control of investigational medicinal products tested in clinical trials within the European Union. The IMPD is submitted as part of clinical trial authorization applications to regulatory authorities. It includes summaries of non-clinical and clinical data and a risk-benefit assessment. The IMPD requirements are harmonized across EU member states under regulations established by the European Medicines Agency to facilitate multinational clinical trials.
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
The Common Technical Document (CTD) is a standardized format for new drug applications agreed upon by international regulatory agencies. It has 5 modules covering administrative information, summaries, quality, non-clinical studies, and clinical studies. The electronic CTD (eCTD) is the electronic version that regulatory agencies now require. eCTD submissions have granular documents linked by XML and allow for increased transparency, ease of review, and benefits like reduced submission time and costs.
The document discusses the abbreviated new drug application (ANDA) regulatory approval process for generic drugs in the United States. It describes the key steps and reviewing bodies involved, including filing review by the Regulatory Support Branch, coordination of reviews by bioequivalence, chemistry, and labeling teams, and final approval. The primary goal of the ANDA process is to determine if the generic drug is bioequivalent to the reference listed drug while ensuring safety and manufacturing quality standards are met.
The document discusses the requirements and contents of an Investigational Medicinal Product Dossier (IMPD) which provides information on the quality, manufacture, and control of investigational medical products (IMPs) used in clinical trials in the European Union. An IMPD includes summaries of nonclinical and clinical data and is required for authorization to perform clinical trials in EU member states. It must provide an overall risk-benefit assessment of the proposed trial based on nonclinical and clinical analyses. A simplified IMPD may be acceptable in some cases such as if the IMP is already authorized. The IMPD covers quality data, nonclinical pharmacology and toxicology data, previous clinical experience, and an overall risk assessment.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
The Common Technical Document (CTD) is an internationally agreed format for organizing the technical requirements submitted to regulatory authorities for drug registration. It provides a harmonized template that is acceptable in all three ICH regions: the U.S., Europe, and Japan. The CTD aims to reduce the resources needed to compile applications, facilitate simultaneous submissions and regulatory information exchange, and allow faster availability of new medicines. It is organized into five modules covering administrative information, summaries, quality, nonclinical reports, and clinical reports. While the CTD format provides benefits like resource savings, there remain limitations as requirements still differ between regions.
The document discusses post-approval regulatory affairs. It notes that the FDA may require post-approval studies to ensure continued safety and effectiveness of approved drugs and devices. Failure to comply with post-approval requirements can result in withdrawal of approval. It also discusses requirements for making and reporting manufacturing and distribution changes to approved applications, including prior approval supplements, changes being effected supplements, and annual reports. Finally, it provides examples of major, moderate, and minor labeling changes that may require different levels of regulatory submission.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
PharmaReady ECTD is a fully integrated web-based electronic common technical document publishing system designed for intuitive content assembly and management of regulatory submissions. It supports submissions to major global health authorities and features automated processes, drag-and-drop functionality, simultaneous multi-agency submissions, and comprehensive validation documentation. Services include implementation support, training, and validation documentation to ensure a smooth rollout. PharmaReady is used by over 110 clients worldwide.
Dossier Management and Regulatory Affairs.Naila Kanwal
The document discusses dossier management for regulatory affairs. It defines a dossier as a collection of detailed information about a subject. Effective dossier management involves planning, formatting, compilation, and review. Key aspects include understanding regulatory requirements, compiling information in a clear format, and cross-checking for errors before submission. Proficiency with software like MS Office and Adobe Acrobat is important for dossier management.
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
Barriers to internationalization–a study of the pharmacy sector in trinidad a...ijsidonlineinfo
This document summarizes a study that examined barriers to internationalization faced by retail pharmacies in Trinidad and Tobago. The study used surveys to measure pharmacies' willingness to internationalize and identify perceived barriers. Three hypotheses were tested: 1) access to finance is a major constraint, 2) strong international networks increase willingness, and 3) younger firms are more willing to internationalize. The results found support for the first two hypotheses but not the third - age was not a significant factor. The study provides insight into challenges small businesses in the pharmacy sector face when considering expanding internationally.
O documento discute as causas do fracasso escolar, incluindo falta de pré-requisitos, rótulos negativos e problemas sociais. Anteriormente, culpava-se os alunos e suas famílias, mas hoje reconhece-se que fatores externos como a performance do professor também influenciam. Não devemos apontar culpados, mas sim buscar novas abordagens, como liderança, clima escolar positivo e capacitação docente.
The document discusses guidelines for Active Substance Master Files (ASMF) and European Drug Master Files (EDMF) in the European Union. Some key points:
- An ASMF/EDMF contains quality and quality control information for an active pharmaceutical ingredient. It has two parts - an applicant part given to marketing authorization applicants, and a restricted part for regulatory authorities.
- The ASMF procedure can be used for new active substances, existing substances not in pharmacopeias, and pharmacopeial substances. It cannot be used for biological substances.
- Marketing authorization applicants must include specified information from the ASMF in their application dossier and have access to the current active substance manufacturer. ASMF
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
This document discusses post-approval regulatory affairs for drugs and medical devices. It explains that the FDA may require post-approval studies to ensure continued safety and effectiveness of approved products. Sponsors must comply with post-approval requirements or approval can be withdrawn. Post-approval changes are categorized as major, moderate, or minor depending on their potential effect. Major changes generally require prior approval from the FDA, while moderate changes require notification 30 days before distribution. Minor changes are reported annually. The document provides recommendations for common post-approval changes including components, manufacturing sites, processes, specifications, packaging, and labeling.
Investigation of medicinal product dossier (IMPD)Himal Barakoti
The document discusses the Investigational Medicinal Product Dossier (IMPD) which contains detailed information on the quality, manufacture, and control of investigational medicinal products tested in clinical trials within the European Union. The IMPD is submitted as part of clinical trial authorization applications to regulatory authorities. It includes summaries of non-clinical and clinical data and a risk-benefit assessment. The IMPD requirements are harmonized across EU member states under regulations established by the European Medicines Agency to facilitate multinational clinical trials.
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
The Common Technical Document (CTD) is a standardized format for new drug applications agreed upon by international regulatory agencies. It has 5 modules covering administrative information, summaries, quality, non-clinical studies, and clinical studies. The electronic CTD (eCTD) is the electronic version that regulatory agencies now require. eCTD submissions have granular documents linked by XML and allow for increased transparency, ease of review, and benefits like reduced submission time and costs.
The document discusses the abbreviated new drug application (ANDA) regulatory approval process for generic drugs in the United States. It describes the key steps and reviewing bodies involved, including filing review by the Regulatory Support Branch, coordination of reviews by bioequivalence, chemistry, and labeling teams, and final approval. The primary goal of the ANDA process is to determine if the generic drug is bioequivalent to the reference listed drug while ensuring safety and manufacturing quality standards are met.
The document discusses the requirements and contents of an Investigational Medicinal Product Dossier (IMPD) which provides information on the quality, manufacture, and control of investigational medical products (IMPs) used in clinical trials in the European Union. An IMPD includes summaries of nonclinical and clinical data and is required for authorization to perform clinical trials in EU member states. It must provide an overall risk-benefit assessment of the proposed trial based on nonclinical and clinical analyses. A simplified IMPD may be acceptable in some cases such as if the IMP is already authorized. The IMPD covers quality data, nonclinical pharmacology and toxicology data, previous clinical experience, and an overall risk assessment.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
The Common Technical Document (CTD) is an internationally agreed format for organizing the technical requirements submitted to regulatory authorities for drug registration. It provides a harmonized template that is acceptable in all three ICH regions: the U.S., Europe, and Japan. The CTD aims to reduce the resources needed to compile applications, facilitate simultaneous submissions and regulatory information exchange, and allow faster availability of new medicines. It is organized into five modules covering administrative information, summaries, quality, nonclinical reports, and clinical reports. While the CTD format provides benefits like resource savings, there remain limitations as requirements still differ between regions.
The document discusses post-approval regulatory affairs. It notes that the FDA may require post-approval studies to ensure continued safety and effectiveness of approved drugs and devices. Failure to comply with post-approval requirements can result in withdrawal of approval. It also discusses requirements for making and reporting manufacturing and distribution changes to approved applications, including prior approval supplements, changes being effected supplements, and annual reports. Finally, it provides examples of major, moderate, and minor labeling changes that may require different levels of regulatory submission.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
PharmaReady ECTD is a fully integrated web-based electronic common technical document publishing system designed for intuitive content assembly and management of regulatory submissions. It supports submissions to major global health authorities and features automated processes, drag-and-drop functionality, simultaneous multi-agency submissions, and comprehensive validation documentation. Services include implementation support, training, and validation documentation to ensure a smooth rollout. PharmaReady is used by over 110 clients worldwide.
Dossier Management and Regulatory Affairs.Naila Kanwal
The document discusses dossier management for regulatory affairs. It defines a dossier as a collection of detailed information about a subject. Effective dossier management involves planning, formatting, compilation, and review. Key aspects include understanding regulatory requirements, compiling information in a clear format, and cross-checking for errors before submission. Proficiency with software like MS Office and Adobe Acrobat is important for dossier management.
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
Barriers to internationalization–a study of the pharmacy sector in trinidad a...ijsidonlineinfo
This document summarizes a study that examined barriers to internationalization faced by retail pharmacies in Trinidad and Tobago. The study used surveys to measure pharmacies' willingness to internationalize and identify perceived barriers. Three hypotheses were tested: 1) access to finance is a major constraint, 2) strong international networks increase willingness, and 3) younger firms are more willing to internationalize. The results found support for the first two hypotheses but not the third - age was not a significant factor. The study provides insight into challenges small businesses in the pharmacy sector face when considering expanding internationally.
O documento discute as causas do fracasso escolar, incluindo falta de pré-requisitos, rótulos negativos e problemas sociais. Anteriormente, culpava-se os alunos e suas famílias, mas hoje reconhece-se que fatores externos como a performance do professor também influenciam. Não devemos apontar culpados, mas sim buscar novas abordagens, como liderança, clima escolar positivo e capacitação docente.
Avaliação da aprendizagem escolar: um ato amorosoAndreza Lira
O documento discute a avaliação da aprendizagem escolar como um ato amoroso, enfatizando que ela deve identificar os atos e situações dos alunos e acolhê-los, ao invés de excluí-los ou classificá-los. A avaliação deve fazer um diagnóstico e incluir o aluno no processo, ao contrário de testes que selecionam e julgam.
The document provides information about the upcoming Common Written Examination (CWE) to be conducted by the Institute of Banking Personnel Selection (IBPS) in September 2014 for recruitment of officers and office assistants in regional rural banks across India. It lists the 56 participating regional rural banks and their head office locations. The eligibility criteria include nationality, age, educational qualifications, physical disability definitions. Candidates qualifying the CWE will be considered for subsequent rounds of selection including interviews to be conducted by individual regional rural banks.
Este documento discute a avaliação escolar e a democratização da educação no Brasil. A avaliação nas escolas geralmente se concentra em notas e julgamentos ao invés de diagnóstico e melhoria, e precisa mudar para apoiar todos os estudantes. Os professores devem envolver estudantes e pais no processo de avaliação para torná-la mais justa e útil para a aprendizagem.
Prática Escolar: Do Erro Como Fonte de Castigo ao Erro Como Fonte de VirtudeAndreza Lira
O documento discute como o erro era tratado historicamente na educação, sendo fonte de castigo, e como hoje é visto como fonte de virtude e aprendizagem. A avaliação da aprendizagem deveria servir de suporte ao aluno, não acrescentando culpa ou castigo quando há insucesso ou erro. O erro é parte do processo de crescimento, não devendo ser visto como algo negativo.
Erro e fracasso_novo. lidia e ana liviaAndreza Lira
Este documento discute o erro e o fracasso no contexto da aprendizagem. Ele afirma que o erro não é necessariamente indício de fracasso, mas parte integrante do processo de aprendizagem. O documento também explora diferentes tipos de erros e suas possíveis interpretações, além de discutir que o fracasso escolar envolve múltiplas variáveis e não é apenas responsabilidade do aluno.
Voltametric determination of acephate pesticide by liquid state lipase enzyma...ijsidonlineinfo
This document summarizes a study that developed an electroanalytical method for determining the organophosphorus pesticide Acephate using liquid state lipase enzyme inhibition. The method is based on measuring the inhibition of lipase enzyme's ability to hydrolyze p-Nitro phenyl acetate to p-Nitro phenol, which is then detected by cyclic voltammetry. The study optimized various parameters such as enzyme concentration, substrate concentration, pH, incubation time and obtained a linear calibration for detecting Acephate concentrations between 100-900 μM. The detection limit was found to be 159.77 μM and the quantification limit was 532.57 μM for Acephate using this lipase enzyme inhibition method.
A simple rp hplc method for simultaneous analysis of pseudoephedrine, bambute...ijsidonlineinfo
This document describes the development and validation of a reverse phase HPLC method for the simultaneous analysis of Pseudoephedrine, Bambuterol, Levocetirizine, and Montelukast in pharmaceutical dosage forms. The method uses a C18 column with a gradient mobile phase of buffer and acetonitrile at a flow rate of 1 mL/min. The compounds were well separated with retention times between 4.1-21.1 minutes. The method was validated for linearity, precision, accuracy and robustness according to ICH guidelines and is suitable for quality control of these drugs in tablets and other dosage forms.
This document provides an overview of services. It likely describes the various types of services offered by a company or organization and may include details about their purpose, availability, costs, and how to access them. The overview aims to inform readers about the scope and nature of the services in a clear and concise manner within a short document.
Ultimate Kung Fu in Fargo offers martial arts classes and has a website with rates and schedules. The website www.ultimatekungfu.com provides information on classes while www.youtube.com/ultimatekungfu features instructional martial arts videos.
Histopathology of intestinal tissue of mastacembelus armatus parasitized by p...ijsidonlineinfo
This document summarizes a research article that studied the histopathological changes in the intestinal tissue of Mastacembelus armatus fish parasitized by the Ptychobothridae cestode parasite Senga Sp. The normal intestinal tissue structure is described. Sections of infected intestine tissue showed the parasite penetrating the mucosal layer and damaging the villi and epithelium. Higher magnifications showed the parasite crossing multiple intestinal layers and reaching near the serosa. The parasite was concluded to have a pathogenic effect and cause damage to the host intestinal tissue to obtain nutrients, making it an important consideration for aquaculture and fish disease management.
Ultimate Kung Fu in Fargo offers martial arts classes and has a website with rates and schedules. The website www.ultimatekungfu.com provides information on classes while www.youtube.com/ultimatekungfu features instructional martial arts videos.
The document is a report by Hamoud Al-Breiki on renewable and non-renewable energy. It defines energy and discusses various types of renewable energy like solar, hydropower and wind. It also discusses non-renewable energy sources like oil, gas and coal. The report covers advantages and disadvantages of both renewable and non-renewable energy. It concludes by mentioning Masdar company and providing references.
Este documento analisa como a avaliação pode contribuir para a aprendizagem em softwares educativos de línguas estrangeiras. Ele discute diferentes concepções de avaliação e como elas estão presentes nos softwares, além de analisar funções da avaliação como diagnóstico e feedback. Também examina tipos de softwares e características relacionadas à organização dos conteúdos e interação.
Photo catalytic degradation of m dinitrobenzene using semiconductor zn o and ...ijsidonlineinfo
The document summarizes a study on the photocatalytic degradation of m-dinitrobenzene using zinc oxide (ZnO) and hydrogen peroxide (H2O2). Various parameters that affect the degradation rate were investigated, including pH, irradiation time, light intensity, substrate concentration, catalyst concentration, and H2O2 concentration. The maximum degradation rate occurred at pH 8.5, with 0.14 grams of ZnO catalyst and 0.30 mL/h of H2O2. The degradation rate increased with light intensity, substrate concentration (up to an optimum level), catalyst amount (up to a saturation point), and H2O2 concentration (until it became excessive). The mechanism of
Alternate teaching learning methods a welcome idea among students!ijsidonlineinfo
1) The study compared the effectiveness of two teaching methods - a PowerPoint presentation versus a blackboard/chalk presentation aided by 3D models.
2) An assessment given after each session found no significant difference in student performance between the two methods. However, feedback indicated that students preferred the use of 3D models as it helped visualize concepts.
3) When the lesson was recapped using a combination of methods, 58% of students rated this approach best over using a single method alone. The study concluded that using multiple teaching methods can make lectures more interesting for students.
Choosingtherightpoliticalmodelforpakistan 130118125219-phpapp02Naqash Aman
Pakistan was created as an Islamic state through the sacrifices of millions who wanted to establish a nation governed by Islamic principles, with authority derived from Allah alone. A dialogue between Muhammad Ali Jinnah and Allama Shabbir Ahmad Usmani discussed that Pakistan's constitution and sovereignty would be limited to the principles prescribed by Islam. The objective of Pakistan's birth was to have a country where Islamic laws and values formed the basis of governance.
Prescription drug user fee act and its influence on review time and budgetSriramNagarajan17
The Prescription Drug User Fee Act (PDUFA) allows the FDA to collect fees from drug companies to fund the review of new drug applications. This reduces the review time from months to years. PDUFA must be renewed every 5 years. It has succeeded in meeting its goals of reduced review times and increased FDA budget from user fees. For 2012, user fees provided over 50% of the FDA drugs budget. PDUFA fees are divided into application, establishment, and product fees to distribute costs fairly among companies. The act has benefited patients by shortening wait times for new drugs and helped companies by reducing financial losses from long reviews.
The document discusses the evolution and goals of the Unique Device Identification (UDI) system, which aims to uniquely identify medical devices and their attributes to improve safety. It outlines the roles of regulatory bodies like the FDA and IMDRF in developing UDI requirements. The UDI system is expected to benefit stakeholders by improving traceability, reducing errors, and enabling efficient recalls. However, implementing UDI presents challenges for medical device manufacturers related to integrating it into organizational processes and systems. Outsourcing partners with expertise in medical device engineering can help manufacturers implement UDI more quickly and cost-effectively.
The document summarizes the review processes for new drug applications in the United States under 505(b)(1), 505(b)(2), and 505(j). It discusses the roles of the FDA and CDER and describes the types of applications, meetings, and fees involved in IND, NDA, and ANDA review processes. The review processes include application submission and review, communication of deficiencies, requests for additional information, inspections, and potential approval or refusal of applications.
India is proposing an ambitious plan to substantially raise spending on providing free drugs for India’s 1.2 billion population. But there are doubts over the plan’s implementation. India wants to spend up to 300 billion rupees ($5.4 billion), or 0.5% of gross domestic product, on procuring drugs to be distributed through governmentrun hospitals and clinics by 2017. Currently, India spends about 60 billion rupees ($1.1 billion), or 0.1% of GDP.
Most government hospitals in India are overcrowded, understaffed and lack medicines and supplies. “Significant shortages in the number of doctors, nurses, paramedics and hospital beds per 1,000 population in India pose a great challenge for speedier
implementation of universal healthcare in the country,” said Tapan Ray, director general of the Organisation of Pharmaceutical Producers of India, or OPPI, a lobby group for Pharma MNCs in India.
The document discusses the challenges of conducting clinical trials in India due to excessive regulation, or "red tape." It provides examples of major pharmaceutical companies moving research and development operations overseas or closing facilities in India due to the bureaucratic hurdles. While India offers cost advantages for clinical trials, the lengthy approval process and inability to conduct certain trials creates disadvantages compared to locations abroad with a more supportive ecosystem.
The document provides information for filing an Investigational New Drug (IND) application in electronic Common Technical Document (eCTD) format with the US FDA. It discusses the objectives of filing an IND for the drug Riociguat to treat pulmonary hypertension. It provides background on CTD and eCTD submission formats. It also includes details on the chemistry, manufacturing, and controls of Riociguat, preclinical and clinical studies, labeling, and stability data required for the IND application in eCTD format.
The document is the annual report of the Government of India's Ministry of Chemicals & Fertilizers Department of Pharmaceuticals for the year 2020-21. It provides an overview of the pharmaceutical and medical devices industry in India. Some key points:
- India is the 3rd largest pharmaceutical producer by volume globally and supplies affordable generic drugs worldwide. It also accounts for 60% of global vaccine production.
- The medical devices industry in India has potential to reach $50 billion by 2025, currently ranking among the top 20 global markets.
- Exports and imports of pharmaceuticals and medical devices in 2019-20 are provided, with exports of medical devices growing and reducing the trade deficit.
The document discusses the investigational new drug (IND) application process. It defines an IND as an application that allows sponsors to legally conduct clinical trials of investigational drugs in humans. The IND process involves preclinical animal testing, filing an INDA application including information on manufacturing and clinical protocols, a 30-day review period by the FDA, and oversight of clinical trials and reporting if approved. It provides details on the various sections, forms, classifications and reviews involved in the IND application and approval process.
This document provides an overview of the medical device and equipment industry in India. It discusses key aspects of the industry including leading companies, drivers of growth, challenges, and recommendations for the government. The medical device industry in India is valued at $2.5 billion but has significant growth potential. While private and foreign investment is increasing, challenges remain around low penetration, affordability, and developing a robust regulatory system on par with global standards.
Regulatory Affairs in the Pharmacy Curriulum A Reviewijtsrd
The Indian pharmaceutical industry is expanding quickly, and there is a need of regulatory affairs specialists to meet the present demands of companies in the face of international competition. The goal of governments to protect public health has led to the development of a relatively new profession known as regulatory affairs. Pharmaceuticals, veterinary medications, medical gadgets, pesticides, agrochemicals, and cosmetics are among the industries where the government regulates the safety and effectiveness of products. And alternative treatments. The pharmaceutical firms in charge of these drugs discovery, development, testing, clinical trials, production, manufacturing, and marketingItems also want to make sure that they are providing products that are secure and beneficial to the health and welfare of the general public. legislative issuesThe international regulatory bodies and the pharmaceutical businesses are connected via specialists. It is needed that they. Akshay Kaware | Prof. Santosh Waghmare | Dr. Hemant Kamble "Regulatory Affairs in the Pharmacy Curriulum: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-7 , December 2022, URL: https://www.ijtsrd.com/papers/ijtsrd52279.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/52279/regulatory-affairs-in-the-pharmacy-curriulum-a-review/akshay-kaware
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
International Overview & Future Medical Devices Regulationsmdbio2009
This document provides an overview of medical device regulations internationally, including in Canada, the United States, Europe, Australia, and Asia. It discusses key regulatory bodies and requirements in each region. It also summarizes Canada's 2007-2012 strategies to modernize its regulatory framework and program, strengthen human resources and funding, improve governance, and foster stakeholder partnerships. Recognition of standards and relationships between different quality systems are also covered. The presentation aims to help organizations understand and navigate international medical device regulations.
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans
Medical device industry 2014 - A Healthcare Sector AnalysisVikas Soni
Medical Device Industry and its impact on Healthcare Sector of India for FY2014 along with Current Scenario of Global, US, EU and Indian Medical device market.
The document discusses the Prescription Drug User Fee Act (PDUFA), which allows the FDA to collect fees from drug manufacturers to fund the new drug approval process. PDUFA has been reauthorized every 5 years since 1997 to provide for timely review of new drug applications. The goals of PDUFA are to review original drug applications, resubmissions, and supplements in order to improve communication between the FDA and drug sponsors. PDUFA may operate to increase or decrease drug risk, as it causes the FDA to undertake more risks to meet performance targets but also provides resources for timely evaluation of drugs' benefits and risks.
The document discusses initiatives by the Government of India to promote research and development in the pharmaceutical sector. It provides details about the Drugs and Pharmaceuticals Research Programme (DPRP) launched by the Department of Science and Technology. DPRP aims to enhance capabilities of the Indian drugs industry through public-private partnerships. It provides grants and soft loans to support collaborative R&D projects between public institutions and industry. Over 50 industry-institutional alliances have been formed under this program.
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
Similar to Usfda generic drug user fee act a complete review (20)
Stabilized compositions of prasugre hydrochloride tabletsijsidonlineinfo
This document summarizes a research article that studied stabilized tablet compositions of prasugrel hydrochloride. Prasugrel is a thienopyridine derivative and ADP receptor antagonist used to reduce cardiovascular events in patients with acute coronary syndrome undergoing percutaneous coronary intervention. The researchers developed tablet formulations using Opadry AMB, a moisture barrier film coating, which showed better stability compared to normal hypromellose coatings. They used a dry direct compression method and evaluated compositions containing prasugrel hydrochloride, mannitol, crospovidone, hypromellose, and magnesium stearate coated with Opadry AMB or Opadry II. The Opadry AMB coated tablets provided
Green synthesis of gold nanoparticles using various extract of plants and spicesijsidonlineinfo
1. The document describes the green synthesis of gold nanoparticles using various plant and spice extracts, which reduce aqueous HAuCl4.3H2O to Au° and stabilize the nanoparticles.
2. Twenty-five plants and four spice extracts were used to synthesize gold nanoparticles, as confirmed by the color change from yellow to various colors and monitoring of surface plasmon resonance using UV-Vis spectroscopy.
3. The phytochemicals in the plant and spice extracts, such as polyphenols, terpenes, and carbohydrates, contain active groups that play an important role in reducing HAuCl4 to Au nanoparticles.
Anthropometric, dietary intakes and exercise habits of niddm in guntur cityijsidonlineinfo
The study examined the dietary habits and exercise patterns of 50 type 2 diabetics in Guntur City, India. It found that over 50% of subjects were obese, with a BMI over 25. The typical meal pattern was 3 meals and 1 snack per day. Common foods restricted were those high in sugar and carbohydrates. However, over 70% included foods like millets, bitter gourd and green leafy vegetables. Nearly half the subjects used indigenous foods like fenugreek seeds to manage their diabetes. Walking was the main form of exercise.
Single rp hplc method for the quantification of aceclofenac, paracetamol and ...ijsidonlineinfo
This document describes a single RP-HPLC method for the quantification of aceclofenac, paracetamol, and chlorozoxazone in formulations. The method utilizes an Inertsil ODS 3V column with a mobile phase of phosphate buffer and acetonitrile in a 67:33 ratio at a flow rate of 1.0 mL/min and detection at 275 nm. The method was validated for specificity, linearity, accuracy, precision, and ruggedness. High resolution was achieved with retention times of 2.1 minutes for paracetamol, 8.8 minutes for chlorozoxazone, and 20.7 minutes for aceclofenac. The method provides a simple, validated approach
Sesame oil cake an inexpensive substrate for neutral protease production by p...ijsidonlineinfo
This document describes research on using sesame oil cake as a substrate for neutral protease production by Penicillium chrysogenum NCIM 737 under solid-state fermentation. Sesame oil cake supported the maximum protease production of the substrates tested. Process parameters like fermentation time, temperature, pH, inoculum age, and initial moisture content were optimized. Maximum protease activity of 172.5 U/gds was obtained at 7 days of fermentation, 25°C, pH 7, with a 7-day old culture at 45% initial moisture content. Supplementing the substrate with sucrose, peptone, and ammonium chloride further increased activity to 197.5 U/gds.
Evaluation of effects of botanical extracts against the pink mealy bug (macon...ijsidonlineinfo
The document evaluates the effects of botanical extracts on the activity of aminotransferases in silkworms fed mulberry leaves infested by the pink mealy bug. Specifically, it studied the impacts of spraying extracts from Azadirachta indica, Ocimum Sanctum, and parthenium hysterophorus on the protease and transaminase activity in silkworm tissues. The results showed that protease and ALAT activity gradually increased in silkworms fed the treated leaves, while AAT activity decreased from day 4 to day 6, though these changes were not statistically significant. The study suggests that foliar spraying of these plant extracts can control pink mealy bugs on mulberry leaves without negatively affecting
Effects of endosulfan and fenvalerate on pyruvate of the freshwater fish, lab...ijsidonlineinfo
The document reports on a study that examined the effects of the pesticides endosulfan and fenvalerate on pyruvate levels in the freshwater fish Labeo rohita. The fish were exposed to sublethal concentrations of the pesticides for 24 hours and 15 days. Pyruvate levels decreased in the brain, gill, kidney, liver, and muscle tissues of the fish after exposure. Fenvalerate exposure resulted in greater decreases in pyruvate levels than endosulfan exposure. The decreases in pyruvate suggest a shift towards anaerobic metabolism in the fish due to pesticide stress.
Study of cladocera species diversity with reference to chydoridae and bosma...ijsidonlineinfo
This document summarizes a study of Cladocera species diversity in the Nira left bank canal and Tarangawadi lake in India. 14 species across 2 families (Bosminidae and Chydoridae) were identified based on appendages like the labrum, antennules, dorsal, ventral, and post abdomen features. In the Bosminidae family, 2 species of Bosmina and Bosminopsis were found. The Chydoridae family contained 6 genera including the genus Alona which had 4 species identified by the presence of ocelli and varied post abdomen shapes.
A Guide to a Winning Interview June 2024Bruce Bennett
This webinar is an in-depth review of the interview process. Preparation is a key element to acing an interview. Learn the best approaches from the initial phone screen to the face-to-face meeting with the hiring manager. You will hear great answers to several standard questions, including the dreaded “Tell Me About Yourself”.
Resumes, Cover Letters, and Applying OnlineBruce Bennett
This webinar showcases resume styles and the elements that go into building your resume. Every job application requires unique skills, and this session will show you how to improve your resume to match the jobs to which you are applying. Additionally, we will discuss cover letters and learn about ideas to include. Every job application requires unique skills so learn ways to give you the best chance of success when applying for a new position. Learn how to take advantage of all the features when uploading a job application to a company’s applicant tracking system.
Job Finding Apps Everything You Need to Know in 2024SnapJob
SnapJob is revolutionizing the way people connect with work opportunities and find talented professionals for their projects. Find your dream job with ease using the best job finding apps. Discover top-rated apps that connect you with employers, provide personalized job recommendations, and streamline the application process. Explore features, ratings, and reviews to find the app that suits your needs and helps you land your next opportunity.
Jill Pizzola's Tenure as Senior Talent Acquisition Partner at THOMSON REUTERS...dsnow9802
Jill Pizzola's tenure as Senior Talent Acquisition Partner at THOMSON REUTERS in Marlton, New Jersey, from 2018 to 2023, was marked by innovation and excellence.
Leadership Ambassador club Adventist modulekakomaeric00
Aims to equip people who aspire to become leaders with good qualities,and with Christian values and morals as per Biblical teachings.The you who aspire to be leaders should first read and understand what the ambassador module for leadership says about leadership and marry that to what the bible says.Christians sh
5 Common Mistakes to Avoid During the Job Application Process.pdfAlliance Jobs
The journey toward landing your dream job can be both exhilarating and nerve-wracking. As you navigate through the intricate web of job applications, interviews, and follow-ups, it’s crucial to steer clear of common pitfalls that could hinder your chances. Let’s delve into some of the most frequent mistakes applicants make during the job application process and explore how you can sidestep them. Plus, we’ll highlight how Alliance Job Search can enhance your local job hunt.
thyroid case presentation.pptx Kamala's Lakshaman palatial
Usfda generic drug user fee act a complete review
1. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
ISSN:2249-5347
IJSID
International Journal of Science Innovations and Discoveries An International peer
Review Journal for Science
Research Article Available online through www.ijsidonline.info
USFDA-GENERIC DRUG USER FEE ACT: A COMPLETE REVIEW
Dept. of Chemistry, Sri Krishnadevaraya University, Anantapur, AP, India
Useni Reddy Mallu* and Anand K
Received: 19-08-2012 ABSTRACT
USFDA has implemented several types user fee acts for human and animal
Accepted: 18-10-2012
medicines, bio-Similar, colors, exports, tobacco and medical devices. After several
discussion and negotiations with Generic Pharmaceutical Association (GPhA), USFDA has
*Corresponding Author
recently implemented Generic Drug User Fee Act (GDUFA) for Generic Drugs. GDUFA key
goals are Safety, Efficacy and Access. From the GDUFA implementation, USFDA will get the
funds approx. $1.5billion over the 2013 to 2017 financial years from the generic players.
The main intention to implement the user fee is to increase the number of reviewers in
USFDA team, speed up the facility inspections and approval process of all types of
applications including the prioritization of the paragraph-IV.
Address:
Keywords: USFDA, Generic Drug User Fee Act (GDUFA) amendments 2012, Drug Master
Name:
File (DMF), ANDA, and GDUFA cover sheet.
Dr. Useni Reddy Mallu
Place:
INTRODUCTION
Sri Krishnadevaraya University
Anantapur, AP, India.
E-mail:
drusenireddymallu@gmail.com
INTRODUCTION
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
117
2. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Scope: This article is intended to provide basic information and general pathway required to adopt during filling of ANDA by
INTRODUCTION
the generic industries.
Purpose: The purpose of this article is
Educate readers on basics of the GUDFA
Enable readers to understand the difference between traditional ANDA and GUDFA adopted ANDA filling.
Summarize a wide documents related to GUDFA published by public USFDA cder domain website.
FDA has User Fee programs (UFP) to fulfill its mission of protecting the public health and accelerating innovation in
Background:
the industry. The collected fees are used to provide the safety and effective medicines to the patients. FDA has user fees for
human and animal drugs, medical and mammography devices, color additives, exports and tobacco products. The Division of
User Fees (DUF) is responsible for the overall management of the program, Office of Financial Management (OFM). The OFM
has collecting the user fee from manufacturer.
USFDA has implemented about thirteen user fee acts for protecting health and providing safety, efficacy medicines for
humans and animals. The lists of user fee acts are represented below.
1. Animal Drug User Fee Act (ADUFA)
2. Animal Generic Drug User Fee Act (AGDUFA)
3. Bio similar User Fee Act (BsUFA)
4. Color Certification (CERTS)
5. Exports Certificate (Exports)
6. Family Smoking Prevention and Tobacco Control Act (Tobacco)
7. Food Safety Modernization Act (FSMA)
8. Freedom of Information Act Fees
9. Generic Drug User Fee Act (GDUFA)
10. Mammography Quality Standards Act (MQSA)
11. Medical Device User Fee and Modernization Act (MDUFMA)
12. Prescription Drug User Fee Act (PDUFA)
13. Tobacco Product Fees
Pharmaceutical industry has grown rapidly by submitting the number of DMFs and ANDAs. FDA has the more backlog
GENERIC DRUG USER FEE ACT (GDUFA)
of Type-II DMF, ANDA applications and inspections (domestic and foreign). In the year 2010, FDA has initiated the discussions
with Generic Pharmaceutical Association (GPhA) and finally the USFDA has implemented the user fee for generic drugs
through GDUFA amendments 2012. Figure-1 to 5 represents increasing the Type-II DMFs and ANDAs application submissions,
backlog details and inspections in the last 10 years (The below figures are copied from the public FDA websites).
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
118
3. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Figure-1: Continued growth in the ANDA submissions in the last ten years.
Figure-2: Type-II DMF submissions for USFDA approval in the last ten years.
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
119
4. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Figure-3: Pending ANDAs at USFDA in the last six years.
Figure-4: FDF inspections in the last ten years.
2010: Initiation of USFDA discussions.
Origin of GDUFA:
2011: FDA has conducted the meetings with GPhA for negotiations and Implementing, drafting the GDUFA.
2012: On July 9, 2012, GDUFA was signed into law by the President. GDUFA draft Guidelines released on Sep-2012.
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
120
5. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Figure-5: API facilities inspections by USFDA in the last ten years.
The purpose of GDUFA is to provide additional funds to USFDA to supplement the traditional annual funding
Why GDUFA is required?
appropriated by Congress. User fee for generic drugs provides the funding to achieve the same surveillance inspection
frequency for both domestic and foreign manufacturers to insure that all industry participants in the U.S. generic drug system
are held to consistent good manufacturing practice (GMP) standards. The three strong scopes of GDUFA are:
Figure-6: GDUFA Key Goals
Safety: Ensure that industry participants, foreign or domestic, who participate in the U.S. generic drug system are held
to consistent high quality standards and are inspected biennially, using a risk-based approach, with foreign and domestic
parity.
Access: Expedite the availability of low cost, high quality generic drugs by bringing greater predictability to the review
times for ANDAs, amendments and supplements.
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
121
6. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Transparency: Enhance FDA’s ability to protect Americans in the complex global supply environment by requiring the
identification of facilities involved in the manufacture of generic drugs, active pharmaceutical ingredients, and improving
FDA’s communications and feedback with industry in order to expedite product access.
USFDA have a proposal for increasing the facility inspections, speed up the review process, increasing the data base
GDUFA Goals:
management, immediate response letters to the applicant and special focus on paragraph-IV submissions. The main goals of
GDUFA are,
Backlog API DMF and ANDAs review
Speed up the review process for all submissions
Increase the facility inspections (Domestic and Foreign)
Increase the Regulatory Research
Prioritization of Paragraph-IV submission
Maintenance of DMFs in the OGD’s external website
Letter to DMF-holder when all deficiencies have been addressed
When requested by a DMF holder within 10 days of receiving a first-cycle deficiency letter, the agency will grant a 30
minute teleconference to the DMF holder.
Perform relevant research on BE of locally acting products, effects of excipients on permeability and absorption, post-
marketing surveillance and physicochemical characterization of complex drug substances
Generic drugs play in providing more affordable, therapeutically equivalent medicine, the Generic Drug User Fee
GDUFA FEE:
program is designed to keep individual fee amounts as low as possible to supplement appropriated funding to ensure that
consumers continue to receive the significant benefits offered by generic drugs which provided more than $824 billion dollars
in savings to the nation’s health care system in the last decade alone.
FDA has tentatively finalized the user fee for generics. Under GDUFA the generic player need to pay the fee to the FDA
agency for Type-II DMF and ANDA submission and facilities. The detailed fee applicability and fee structure has represented in
the table-1; Figure-7.
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
122
7. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Figure-7: GDUFA user fee
Figure-8: GDUFA user fee applicability and fee types
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
123
8. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Application Fees:
Backlog fees are in year 1 [(Year 1 Oct 1, 2012 to Sept 30, 2013) for ANDAs pending review at the date of program
Backlog fees:
implementation] and ANDA and Post-Approval Study (PAS) fees, as well as DMF first reference fees in all years.
Both finished dosage form manufacturer and API facilities with a modest fee differential reflecting the added costs of
Facility Fees:
overseas inspection.
Fees will be derived from both applications and facilities in a 30%-70% split. Fees will be split between finished
Source of Fees:
dosage form manufacturers and active pharmaceutical ingredient manufacturers in an 80%-20% split.
As per the GDUFA agreement all API, Finished Dosage Forms (FDF) facilities and applicants of DMF, ANDA are need to
GDUFA Fee agreement:
pay the user fee. Details of GDUFA fee agreement are,
Funding level = inflation adjusted $299M/year
Fees for Applications and Facilities
Applications in the backlog (year 1 only) Involved in manufacture of generic drugs,
Applicants Facilities
Drug master file fee whether Active Pharmaceutical Ingredient (API)
ANDA and prior approval supplement (PAS) filing or Finished Dosage Form (FDF), domestic or
fee foreign.
Exemption from fees: Positron Emission Tomography (PET) drugs
Individual fees calculated/published upon implementation and Order of magnitude lower than PDUFA fees
80% from finished dosage form manufacturers, 20% from API manufacturers
Critical splits:
70% from facility fees, 30% from application fees
In year 1, $50M from backlog fee, so above splits are slightly different
Figure-9: GDUFA user fee partition
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
124
9. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Total revenue for 2013 is as follows,
Table-1: USFDA total revenue for FY 2013
Backlog Fee ------ $ 50
Fee type % as per the GDUFA After partition from $ 299
ANDA/PAS 24% $ 59.8
DMF 6% $ 14.9
API Facility 14% $ 34.9
FDF Facility 56% $ 139.4
100% $ 299
Table-2: User fee details as per the GDUF Act
Total Value
Backlog Fee
Requirement Payment 1st year statutorily directed revenue target Effective date
Pending ANDA applications as on Oct- Once $50 million divided by the total No. of Original Oct-31st 2012
frequency and method of calculating individual fee
1, 2012 without a tentative approval ANDAs pending on Oct-1, 2012
Any original ANDA that has not been withdrawn, tentatively approved, or approved by September 28, 2012, is
Details:
considered pending and is subject to a backlog fee.
The backlog fee will be determined based on the number of original ANDAs pending at the start of the business day on
October 1, 2012. In accordance with GDUFA, FDA will divide $50 million by the number of original ANDAs pending to
arrive at the amount of the individual one-time backlog fee, which will be due for each pending original ANDA.
Absent withdrawals, there could be 3,000 pending original ANDAs on October 1, 2012. A number of these applications
are old and incomplete and may be withdrawn by applicants prior to October 1, 2012 to avoid incurring the backlog
fee.
The ANDA applicant should notify the Office of Generic Drugs (OGD) in writing with the request to withdraw the
application. To avoid the backlog fee, written notification must be received by September 28, 2012.
One-time calculation for FY13 and remains in effect for FY14-17.
Fee = $50 Million / number of ANDAs in backlog population
(Example: If backlog population = 2000 ANDAs, then fee is $25,000 for each ANDA).
DMF Fee
Requirement Payment frequency 1st year statutorily directed Effective
revenue target and method date
A type II API-DMF holder whose DMF Once for each API-DMF, no later ~$15 million divided by Oct-31st
of calculating individual fee
is referenced by an initial letter of than when first letter of current estimates of annual No. 2012
authorization in a generic drug authorization is submitted. of DMF application
submission on or after Oct-1st 2012
Only type-II API DMFs need to pay the GDU fee and effective date is Oct-1st 2012
Details:
GDUFA does not make a distinction between DMFs submitted before or after October 1, 2012. Holders of DMFs
reviewed prior to GDUFA implementation must pay the one-time DMF fee if their DMF is referenced in a new generic
drug submission on or after October 1, 2012
A one-time application fee for a Type II Drug Master File (DMF) that is to be referenced on or after October 1, 2012 in a
generic drug submission (new ANDA, supplement or amendment).
A Type II DMF covers the manufacture of an active pharmaceutical ingredient (API) or drug substance.
DMF fee can be paid by DMF holder before a letter of authorization requested by the ANDA holder. The advantage for
DMF holders are the Fee paid DMF will undergo an initial completeness assessment by USFDA using the factors
(factors will be published in forthcoming USFDA guidance) and if DMF passes the completeness assessment it will be
placed on a publicly available list of DMF available for reference
FY13 Fee = 6% of $249 Million / number of estimated Type II DMFs referenced for the first time in FY13. (Example: If
Type II DMFs = 350, then DMF fee is $42,686.)
DMF fee is incurred when a generic drug submission references the Type II DMF for the first time on or after October
1, 2012.
The FY13 fee due date is dependent on the later of the following:
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
125
10. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Date of first generic drug submission that references Type II DMF
30 calendar days after fee amount is published in the Federal Register
30 calendar days after enactment of appropriations act
Generic Drug Submission Fees
Requirement Payment 1st year statutorily directed revenue target and Effective
ANDA and PAS Fee: An applicant Once, at time ~$60 million divided by a weighted average of Oct-31st
frequency method of calculating individual fee date
submitting an ANDA or PAS on or of submission current estimates of annual ANDA and PAS 2012
after Oct-1st 2012 of ANDA or applications.
Fee for API not referenced to as (a) PAS (a)(3) (F) ^Fee is expected to generate a small Oct-31st
(3) (F) fee ^ portion of the total above. 2012
Each applicant that submits, on or after October 1, 2012, an abbreviated new drug application (ANDA) or a prior
Details:
approval supplement (PAS) shall be subject to a fee.
User fees are required for all PASs (including labeling) that require prior approval under FDA regulations.
Changes-Being-Effected (CBE-0 and CBE-30) supplements are not required to pay a user fee. FDA reserves the right to
change any CBE to a PAS. If changed, the applicant will be notified to resubmit its application as a PAS and to pay the
PAS user fee.
For FY13, 24% of $249 million will be collected for ANDA/PAS fees. This amounts to $59.76 million.
ANDA applications may cost about $56,000 per application. PAS applications will be half that amount at $28,000 per
application.
The FY13 fee due date is dependent on the later of the following:
Date of ANDA / PAS submission
30 calendar days after fee amount is published in the Federal Register
30 calendar days after enactment of appropriations act
^ The information related (a)(3)(F) fee is as follows,
If a generic (ANDA, amendment to an ANDA or a PAS to an ANDA) drug submission includes API information other
than by reference to a DMF – e.g., the applicant manufactures an API in its own facility or facilities – is the applicant
required to pay an additional fee?
Yes. The applicant is required to pay an API-related fee for each API manufactured in its own facility or facilities for
which it has not previously paid an API-related fee. As with a DMF fee, this fee is paid only once.
The amount of the API-related fee is a function of the number of APIs referenced in the application and the number of
facilities in which those APIs are manufactured. If the ANDA references more than one facility as manufacturing each
API, the applicant must pay the API-related fee for each such facility.
Facility Fee
Requirement Payment frequency 1st year statutorily Effective date
directed revenue
target and method
of calculating
Active The owner of a facility identified or Annually ~$174 million total
individual fee
Pharmaceutical intended to be identified, in at API: ~$35 million divided
Ingredient least on generic drug submission by number of API facilities.
(API) that is pending or approved to FDF: ~$139 million divided by number of
Finished produce one or more generic drug FDF facilities.
Dosage Forms finished dosage form (FDF) and or Facilities located outside of the US and its
(FDF) APIs territories and possessions will pay a higher
fee reflecting the increased costs of
inspection.
Facilities that manufacture or intend to manufacture generic drugs active pharmaceutical ingredients(API),
Details:
finished dose formulas(FDF), or both
Sites and organizations that pack human generic drugs
Sites where bioanalytical studies are conducted
Sites where clinical research is conducted
Sites where contract analytical testing is conducted
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
126
11. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Facilities that produce positron emission tomography(PET) drugs or API of such drugs
For FY13, the target revenue will be divided by the number self-identified API and FDF facilities, adjusted for
expectations about how many of each will be located outside the US. The statute calls for a differential to be applied
to foreign facilities, and dictates that the difference be at least $15,000 and not more than $30,000 above the
analogous amount for a US facility.
The FY13 fee due date is dependent on the later of the following:
45 calendar days after fee amount is published in the Federal Register
30 calendar days after enactment of appropriations act
The facility will be placed on a publicly-available arrears list if the facility fee is not paid in full within 20 days of the
due date.
No new abbreviated new drug application (ANDA) referencing such facility will be received.
All APIs and FDFs manufactured in such facilities will be deemed misbranded.
FDA has released the user fee process details for generics and it includes the cover sheet and user registration for fee
GDUFA FEE PAYMENT PROCESS:
payment. The high level process for submitting a Generic Drug User Fee Cover Sheet is:
1. Register in the User Fee System by creating a secure user account
2. Submit a Generic Drug User Fee Cover Sheet electronically
3. Submit a payment for the Generic Drug User Fee Cover Sheet
All generic drug organization can initiate the fee payment process from Oct-1 2012 and for user fee payment applicant
need to create the GDUFA cover sheet. This cover sheet will calculate the fee value for all type of user fees. User fee should be
paid after completing the generation of GDUFA cover sheet.
Figure-10: GDUFA user fee payment process steps
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
127
12. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
GDFUA fees apply only to generic drug manufactured for human use.
GDUFA cover sheet creation:
Payment submission: Generic applicant can pay the user fee by using Automated Clearing House (ACH) direct deposit
or Credit card payment (Pay.gov) or send payment by check, bank draft, U.S. postal money order, or wire transfer. Payment
must be made in U.S currency drawn on a U.S. bank by electronic payments. Generally, USFDA will not invoice for fee’s and
expects that firms will self-identify and pay. However, in rare and unusual circumstances, USFDA may find it necessary to issue
an invoice. Positron Emission Tomography (PET) drug manufacturers are the only human generic drug manufacturers
excluded from payment of GDUFA fees. They are, however, required to self-identify. PET manufacturers should complete a
generic drug user fee cover sheet for $0.
No reduced fees available for small business or others. As USFDA determines that small generic companies are expected to
benefit significantly from reductions in the review time needed to commercialize their products and from the certainty
associated with performance review metrics and program efficiencies.
Please visit the for GDUFA user fee payment for all type of payments.
https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp
Review of Generic drug submissions post GDUFA
USFDA will expedite review of paragraph IV ANDA application that is submitted on the first day that any valid Paragraph IV
application for the drug in question is submitted. This added to current expedite process like President’s Emergency Plan for
AIDS Relief (PEPFAR), product for which a nationwide shortage has been identified, etc.
GDUFA adds a new requirement to USFDA’s existing refuse to receive policy with respect to payment of fees and the time of
receipt of an ANDA.
Failure to pay an ANDA fee within 20 calendar days of the applicable due date will result in the ANDA not being received.
Failure to pay the fee for a DMF referenced in the ANDA within 20 calendar days of the date that FDA provides
notification of that failure will result in the ANDA not being received.
Failure to pay a facility fee for any facility referenced in the ANDA within 20 calendar days of the date that FDA provides
notification of that failure will result in the ANDA not being received.
If an application is substantially complete except for failure to pay the ANDA fee, or the failure to pay the facility fee
within 20 days of notification, the application will be deemed received as of the date the fee is paid.
FDA will publish further guidance on any other changes to its refuse to receive policy for public comment in advance of their
implementation.
USFDA continue to accept applications in paper format for the time being. Applications received in paper format after October
1, 2012, however, will not be included as part of the new performance metrics established in GDUFA. Additionally, electronic
submissions will be required 24 months after issuance of final electronic submission guidance.
complete response Level: An applicant may request a 30-minute teleconference within ten business days after FDA issues a
Process for requesting a teleconference to clarify deficiencies and answer questions following FDA’s issuance of a
first-cycle review complete response letter to discuss the deficiencies noted in the letter. The request for a teleconference
must be submitted in writing to the ANDA file and appropriately identified on its cover page as a “Post Complete Response
Teleconference Meeting Request.” The request should include a list of specific written questions for discussion. The scope of
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
128
13. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
the questions should be limited to the content of FDA’s complete response letter. Priority for such teleconferences will be
given to expedited and first major amendment applications and other applications
After October 1, 2012, any ANDA/PAS not considered to have been received for scientific reasons is refunded 75% of
GDUFA Limitations:
the application fee. Refunds for overpayment and payments in error must be requested in writing within 180 days of payment.
The Office of Financial Management (OFM) processes the refunds. All inquiries regarding refunds should be addressed by
OFM.
Address for Payment (Note: USFDA will not be able to process the payment correctly without Firms GDUFA cover sheet PIN
(Payment Identification Number)).
Check payment by mail: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000.
Check payment by delivered by a courier service: U.S. Bank, Attn: Government Lockbox 979108, 1005 Covention Plaza, St.
Louis, MO 63101.
Wire Transfer Payment:
New York Federal Reserve Bank, US Department of Treasury,
TREAS NYC, 33 Liberty Street, New York, NY10045
FDA Deposit Account Number: 75060099
US Department of Treasury Routing/Transit number: 021030004
SWIFT Number: FRNYUS33
1350 Piccard Drive, Suite 200A, Rockville, MD20850.
Beneficiary: FDA
If needed for accounting purposes, FDA’s tax identification number is 53-0196965.
Note: a) Wire Transfers to the Department Of The Treasury are distinct from online ACH payments via Pay.gov.
b) If wire transfer done by financial institutions than the fees should include the fees for handling wire transfers.
c) The total fee amount should be paid at least 1 day before the submission arrives at USFDA.
1) The date the submission was received by USFDA (If fees paid earlier to this date).
FDA records as the submission receipt date the later of the following:
2) The date USFDA is notified that payment has been received (If ANDA submitted earlier to this date).
Phone: (301) 796-7200
User Fee Helpdesk:
Email: userfees@fda.gov
Mail: Food and Drug Administration, User Fees Financial Support Team, 1350 Piccard Drive, Suite 200A, Rockville, MD20850.
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
129
14. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
Figure-11: GDUFA user fee Details and Time lines
GUDFA implementation will provide additional funds to USFDA. These additional funds will help the USFDA to
CONCLUSION
increase the facility inspections, speed up the review process and increasing the data base management. In turn to GDUFA
implementation, USFDA like to provide the significant benefit to industries from reductions in the review time needed to
commercialize their products and from the certainty associated with performance review metrics and program efficiencies.
Further, USFDA provided metric goal/measurement for Original ANDA review as
60% of submission within 15 months for FY 2015
75% of submission within 15 months for FY 2016
90% of submission within 10 months for FY 2017
Expedite paragraph IV (Day 1 submissions) submission FY 2013 and FY 2014
For Backlog metrics, the review and act on 90% of backlog applications pending on Oct 1, 2012 by end of FY 2017.
The authors do not claim anything; the purpose of this review is solely educational. This article is built on the
DISCLAIMER
information provided by the public USFDA CDER domain website
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
130
15. Useni Reddy Mallu et al., IJSID, 2012, 2 (5), 117-131
1. CDER’s MAPP 6050.1, Refusal to Accept Application for Filing From Applicants in Arrears.
REFERENCES
2. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm.
3. Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act, and its addendum at the guidance Web page.
4. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
5. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm.
6.
7. http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf
FDA guidelines: Self-Identification of Generic Drug Facilities, Sites, and Organizations.
8. http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM296451.pdf
9. http://www.drugstorenews.com/article/generic-drug-user-fee-act-passes-senate
10. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm316790.htm
11. http://www.gpo.gov/fdsys/pkg/FR-2012-07-26/html/2012-18232.htm
12. http://pharma.about.com/od/FDA/a/2012-Renewal-Of-The-Prescription-Drug-User-Fee-Act-Pdufa.htm
13. http://www.rediff.com/money/report/us-to-charge-fee-on-generic-drug-sale-application/20120621.htm
14. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm316790.htm
15. https://userfees.fda.gov/OA_HTML/gdufaFAQ.html
16. http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf
17. http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061432.html
18. https://smallbusiness.dnb.com/establish-your-business/12334338-1.html
19. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm0731
64.htm
20. http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm061432.htm
21. https://smallbusiness.dnb.com/establish-your-business/12334338-1.html
22. http://www.fda.gov/edrls
24. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM322676.pdf
23. http://www.fda.gov/RegulatoryInformation/FOI/PrivacyAct/
International Journal of Science Innovations and Discoveries, Volume 2, Issue 5, September-October 2012
131