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The document discusses the New Drug Application (NDA) process for obtaining marketing approval of new pharmaceutical drugs from the U.S. Food and Drug Administration (FDA). An NDA includes information on ingredients, manufacturing, non-clinical and clinical data, and proposed labeling. It allows the FDA to determine a drug's safety, efficacy, and quality. The application must follow specific content and format regulations under 21 CFR part 314, and the FDA has 180 days to review the NDA and decide whether to approve, issue an approvable letter, or not approve the application for marketing. A similar process exists in India under Form 44, which requires administrative, quality, non-clinical, and clinical information across five modules for drug
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Nda
This document provides an overview of the New Drug Application (NDA) process. It discusses what an NDA is, its goals, forms, contents, guidance documents, submission process, and review/approval. Key points include that an NDA is required for marketing approval of new drugs in the US and contains data from clinical trials demonstrating safety and effectiveness. The review process evaluates these factors and can result in approval or refusal. Guidance documents provide guidelines for preparing and submitting the various sections of an NDA to the FDA.
ANVISA
The Brazilian Health Surveillance Agency (ANVISA) regulates health products and services in Brazil. It oversees drug approval and registration, medical devices, food safety, tobacco and other areas. ANVISA aims to protect public health through sanitary control of production, marketing and ports of entry. It is part of the National Health Surveillance System and linked to the Ministry of Health. The registration process for new drugs involves pre-registration clinical trials, submitting documentation for approval, and post-registration monitoring and changes. ANVISA also regulates in vitro diagnostics and provides vaccination requirements for international travelers.
NEW DRUG APPLICATION
The document provides an overview of the New Drug Application (NDA) process used in the United States to gain approval for new drugs. It discusses how the NDA process has evolved since 1938 to require evidence of both safety and efficacy. It also describes the various sections required in an NDA, including summaries of clinical data, chemistry and manufacturing, labeling, and safety information. The review process for an NDA by the FDA is also summarized, including timeframes for filing and reviewing an application.
NEW DRUG APPLICATION (NDA)
Introduction
Brief description of the drug and the therapeutic class to which it belongs
Chemical and pharmaceutical information
Animal Pharmacolog
Animal Toxicology
Human/Clinical Pharmacology phase I
Therapeutic exploratory trials (Phase II)
Therapeutic confirmatory trials (Phase III)
Special Studies Geriatrics, pediatrics, pregnant or nursing women
Regulatory status in other countries
Prescribing information
Samples and Testing Protocol/s
DMF Drug Master File
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:
THERAPEUTIC GOODS ADMINSTRATION
Therapeutics Goods Administration(TGA) is a unit of the Australian Government Department of Health and Ageing, is responsible for administering the act.
IND INDA ANDA Application
This document discusses Investigational New Drug (IND) applications and New Drug Applications (NDA). It provides details on the process for approval of new drugs in the US and India. Some key points include:
- An IND must be filed with the FDA before beginning clinical trials of an investigational new drug in humans. It contains information on pre-clinical studies, manufacturing, and clinical protocols.
- In India, a similar process involves submitting an application on Form 44 to the Central Drugs Standard Control Organization along with required documents and fees.
- An NDA is submitted to formally request approval to market a new drug after Phase III trials. It contains extensive data from non-clinical and clinical studies in a
New drug application
The document discusses the three types of New Drug Applications (NDAs) used in the United States to seek FDA approval for new pharmaceutical products. A "full" NDA contains clinical trial data proving safety and efficacy. A 505(b)(2) application relies partly on published information and can potentially save time and money compared to a full application. It is best suited for products representing limited changes to previously approved drugs, like new formulations or indications. An abbreviated application under 505(j) is for generics proving only bioequivalence to an existing drug.
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Nda
This document provides an overview of the New Drug Application (NDA) process. It discusses what an NDA is, its goals, forms, contents, guidance documents, submission process, and review/approval. Key points include that an NDA is required for marketing approval of new drugs in the US and contains data from clinical trials demonstrating safety and effectiveness. The review process evaluates these factors and can result in approval or refusal. Guidance documents provide guidelines for preparing and submitting the various sections of an NDA to the FDA.
ANVISA
The Brazilian Health Surveillance Agency (ANVISA) regulates health products and services in Brazil. It oversees drug approval and registration, medical devices, food safety, tobacco and other areas. ANVISA aims to protect public health through sanitary control of production, marketing and ports of entry. It is part of the National Health Surveillance System and linked to the Ministry of Health. The registration process for new drugs involves pre-registration clinical trials, submitting documentation for approval, and post-registration monitoring and changes. ANVISA also regulates in vitro diagnostics and provides vaccination requirements for international travelers.
NEW DRUG APPLICATION
The document provides an overview of the New Drug Application (NDA) process used in the United States to gain approval for new drugs. It discusses how the NDA process has evolved since 1938 to require evidence of both safety and efficacy. It also describes the various sections required in an NDA, including summaries of clinical data, chemistry and manufacturing, labeling, and safety information. The review process for an NDA by the FDA is also summarized, including timeframes for filing and reviewing an application.
NEW DRUG APPLICATION (NDA)
Introduction
Brief description of the drug and the therapeutic class to which it belongs
Chemical and pharmaceutical information
Animal Pharmacolog
Animal Toxicology
Human/Clinical Pharmacology phase I
Therapeutic exploratory trials (Phase II)
Therapeutic confirmatory trials (Phase III)
Special Studies Geriatrics, pediatrics, pregnant or nursing women
Regulatory status in other countries
Prescribing information
Samples and Testing Protocol/s
DMF Drug Master File
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:
THERAPEUTIC GOODS ADMINSTRATION
Therapeutics Goods Administration(TGA) is a unit of the Australian Government Department of Health and Ageing, is responsible for administering the act.
IND INDA ANDA Application
This document discusses Investigational New Drug (IND) applications and New Drug Applications (NDA). It provides details on the process for approval of new drugs in the US and India. Some key points include:
- An IND must be filed with the FDA before beginning clinical trials of an investigational new drug in humans. It contains information on pre-clinical studies, manufacturing, and clinical protocols.
- In India, a similar process involves submitting an application on Form 44 to the Central Drugs Standard Control Organization along with required documents and fees.
- An NDA is submitted to formally request approval to market a new drug after Phase III trials. It contains extensive data from non-clinical and clinical studies in a
New drug application
The document discusses the three types of New Drug Applications (NDAs) used in the United States to seek FDA approval for new pharmaceutical products. A "full" NDA contains clinical trial data proving safety and efficacy. A 505(b)(2) application relies partly on published information and can potentially save time and money compared to a full application. It is best suited for products representing limited changes to previously approved drugs, like new formulations or indications. An abbreviated application under 505(j) is for generics proving only bioequivalence to an existing drug.
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The document provides an overview of the Investigational New Drug Application (IND) process. An IND is required before beginning clinical trials of an unapproved drug and provides the FDA with data to assess risks to human subjects. The IND application includes a cover sheet, table of contents, general investigation plan, investigators brochure outlining the clinical protocol, chemistry and manufacturing data, pharmacological/toxicological data, and information on previous human exposure. It describes the content and format requirements for an IND as specified in 21 CFR part 312 regulations. The IND allows companies to initiate clinical studies of new drug products and obtain marketing approval.
Investigational new drug ,orange book,understanding on 505(b) (2) applications
This document discusses investigational new drug applications, the Orange Book, and 505(b)(2) applications. It provides an overview of the IND process including when an IND is needed, the content of an IND application, annual reporting requirements, and classifications of INDs. It also describes the Orange Book's listing of approved drugs and their therapeutic equivalence ratings. Finally, it gives a brief explanation of 505(b)(2) applications, including what products are allowed and examples of 505(b)(2) NDAs.
Abriviated new drug application
The document discusses key aspects of Abbreviated New Drug Applications (ANDAs), including:
1. ANDAs contain data submitted to FDA for review and approval of generic drug products. Once approved, generics can be marketed as lower-cost alternatives.
2. Guidelines provide formats for ANDA sections including chemistry, manufacturing, and bioequivalence data. Electronic submissions are encouraged for consistency and rapid review.
3. Manufacturing and control requirements are important for ANDA approval. From 1977-1992, 105 applications were not approved due to issues in this area.
4. The Hatch-Waxman Act established 180 days of generic marketing exclusivity for the first ANDA applicant challenging a patent
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This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
Hatch Waxman Act
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Abbreviated New Drug Application (ANDA)
This presentation gives a complete brief idea of how FDA regulates the marketing of Generic drugs. An application has to be filled out for the approval of marketing generic drugs. ANDA form has to be filled and submitted for this purpose.
Cdsco ppt
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
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The document discusses guidelines for supplemental new drug applications (sNDAs) according to the US FDA. It outlines three categories of variations - major, moderate, and minor - based on their potential impact. Major changes require prior approval and could impact safety or efficacy. Moderate changes require submission 30 days before distribution or upon FDA receipt. Minor changes only require description in the annual report. The document provides examples of changes in manufacturing sites, processes, specifications, container closure systems, and labeling that would fall under each category. Close monitoring and reporting of any post-approval changes is recommended to ensure the quality, safety and efficacy of pre-qualified products are not adversely affected.
Clinical trial process
The clinical trial process involves planning, implementing, and analyzing clinical studies. The planning stage includes developing the study protocol and case report forms, designing the database, selecting study sites, and obtaining regulatory approval. During implementation, sites are activated, patients are screened and enrolled, data is collected and entered, and the database is locked. In the analysis stage, statistical analysis is conducted according to the analysis plan and clinical study reports are generated for regulatory submission. The goal is to carefully plan and implement the study to generate high quality data that can be accurately analyzed to draw clear conclusions.
Comparison of Clinical Trial Application requirement of India, USA and Europe.
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
CDSCO (regulatory affairs)
The Central Drugs Standard Control Organization (CDSCO) is the main regulatory body for pharmaceuticals, medical devices, and clinical trials in India. CDSCO approves new drugs, regulates import/export and manufacturing of drugs, medical devices, and cosmetics. It has various zonal and regional offices. The document outlines CDSCO's role in drug approval process, clinical trials, regulation of cosmetics, and the new Medical Device Rules of 2016.
ANDA Submission.pptx
An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to submit an application to the FDA to obtain approval for generic versions of approved drug products. An ANDA contains data to demonstrate the generic drug is equivalent to the reference listed drug in terms of active ingredients, dosage form, strength, route of administration, quality, and performance characteristics. If approved, the generic drug manufacturer can then produce and market a lower-cost alternative to the public. The ANDA submission must follow the Common Technical Document format and include information in Modules 1-5, with the exception of nonclinical studies. Electronic submissions via eCTD format are now mandatory.
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The document discusses the various phases of clinical drug development. It describes Phase I trials as initial safety testing in small groups of healthy volunteers. Phase II trials assess safety and efficacy in a small group of patients and explore optimal dosing. Phase III trials demonstrate safety and efficacy in large patient groups. Phase IV trials monitor long-term safety and efficacy after market approval. The document provides details on objectives, patient numbers, study length and progression rates for each phase of clinical drug development.
Snda
The document discusses guidelines for supplemental new drug applications (sNDAs) submitted to the FDA for post-approval changes. It categorizes changes as major, moderate or minor based on their potential impact. Major changes like new manufacturing sites or processes require prior approval. Moderate changes require submission 30 days before distribution or when received by FDA. Minor changes are described in annual reports. The types and levels of data required to support each change category are also outlined.
21 cfr part 50
The document outlines regulations regarding informed consent for biomedical research involving human subjects. It states that informed consent must be obtained from all research participants or their legal guardians. Informed consent documents must include key information such as the study's purpose and procedures, risks and discomforts, benefits, confidentiality protections, and participants' rights to withdraw. Researchers have obligations to fully inform participants and respect their autonomy by ensuring participation is voluntary and without coercion. Special procedures are required for vulnerable populations like children.
ANDA
The document provides information about abbreviated new drug applications (ANDAs), which are designed to allow approval of generic drug products that are equivalent to already approved brand name drugs. An ANDA must show a generic drug is comparable to the reference drug in dosage form, strength, quality and performance. It does not require preclinical and clinical trials but must demonstrate bioequivalence through bioavailability and bioequivalence studies. The ANDA contents and review process are outlined according to the Common Technical Document format in five quality, nonclinical, and clinical modules.
NEW DRUG APPLICATION ( NDA)
The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
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This presentation explains in brief the process, types, requirements, and conditions where PAS is needed to submit by drug manufacturers.
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This document provides an overview of Vineeth Kumar Ekbote's lab presentation on new drug applications (NDAs). The presentation covers what an NDA is, the goals and process of an NDA, the forms and contents required in an NDA submission, guidance documents for NDAs, and how NDAs are reviewed and approved by the FDA. The presentation also describes the various sections required in an NDA, including the application summary, chemistry and manufacturing controls, clinical data, and labeling.
NDA ANDA IND by Anthony Crasto
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It begins with an overview of the drug development process, then describes the goal and contents of an NDA, including clinical data from trials and information on safety, efficacy, and manufacturing. It also classifies types of NDAs.
The document then discusses ANDAs for generic drugs, noting they do not require new clinical trials but must demonstrate bioequivalence to the brand drug. It covers patent certification requirements for ANDAs.
In conclusion, the key differences between NDAs and ANDAs are summarized, with ANDAs taking less time and money but
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Investigational new drug application (ind)
The document provides an overview of the Investigational New Drug Application (IND) process. An IND is required before beginning clinical trials of an unapproved drug and provides the FDA with data to assess risks to human subjects. The IND application includes a cover sheet, table of contents, general investigation plan, investigators brochure outlining the clinical protocol, chemistry and manufacturing data, pharmacological/toxicological data, and information on previous human exposure. It describes the content and format requirements for an IND as specified in 21 CFR part 312 regulations. The IND allows companies to initiate clinical studies of new drug products and obtain marketing approval.
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This document discusses investigational new drug applications, the Orange Book, and 505(b)(2) applications. It provides an overview of the IND process including when an IND is needed, the content of an IND application, annual reporting requirements, and classifications of INDs. It also describes the Orange Book's listing of approved drugs and their therapeutic equivalence ratings. Finally, it gives a brief explanation of 505(b)(2) applications, including what products are allowed and examples of 505(b)(2) NDAs.
Abriviated new drug application
The document discusses key aspects of Abbreviated New Drug Applications (ANDAs), including:
1. ANDAs contain data submitted to FDA for review and approval of generic drug products. Once approved, generics can be marketed as lower-cost alternatives.
2. Guidelines provide formats for ANDA sections including chemistry, manufacturing, and bioequivalence data. Electronic submissions are encouraged for consistency and rapid review.
3. Manufacturing and control requirements are important for ANDA approval. From 1977-1992, 105 applications were not approved due to issues in this area.
4. The Hatch-Waxman Act established 180 days of generic marketing exclusivity for the first ANDA applicant challenging a patent
Regulation Governing Clinical Trials In India,USA and Europe.
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
Hatch Waxman Act
The Hatch Waxman Act established provisions to balance the interests of branded and generic drug manufacturers as well as consumers. It created the Abbreviated New Drug Application (ANDA) process to streamline generic approval. It also provides incentives like exclusivity periods and a 30 month stay on generic approval to encourage drug development while facilitating generic competition through the ANDA pathway. The Act aims to reduce drug costs over time through increased generic competition.
Abbreviated New Drug Application (ANDA)
This presentation gives a complete brief idea of how FDA regulates the marketing of Generic drugs. An application has to be filled out for the approval of marketing generic drugs. ANDA form has to be filled and submitted for this purpose.
Cdsco ppt
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for approving new drugs, medical devices, and clinical trials. CDSCO has headquarters in New Delhi and is overseen by the Drug Controller General of India. It has various zonal and sub-zonal offices that perform GMP audits, inspections, and quality control tests. CDSCO uses a multi-step process to approve clinical trials, drugs, cosmetics, and medical devices that involves submitting documents and gaining permission from the DCGI. It also has an online portal called SUGAM to streamline the application process.
Snda
The document discusses guidelines for supplemental new drug applications (sNDAs) according to the US FDA. It outlines three categories of variations - major, moderate, and minor - based on their potential impact. Major changes require prior approval and could impact safety or efficacy. Moderate changes require submission 30 days before distribution or upon FDA receipt. Minor changes only require description in the annual report. The document provides examples of changes in manufacturing sites, processes, specifications, container closure systems, and labeling that would fall under each category. Close monitoring and reporting of any post-approval changes is recommended to ensure the quality, safety and efficacy of pre-qualified products are not adversely affected.
Clinical trial process
The clinical trial process involves planning, implementing, and analyzing clinical studies. The planning stage includes developing the study protocol and case report forms, designing the database, selecting study sites, and obtaining regulatory approval. During implementation, sites are activated, patients are screened and enrolled, data is collected and entered, and the database is locked. In the analysis stage, statistical analysis is conducted according to the analysis plan and clinical study reports are generated for regulatory submission. The goal is to carefully plan and implement the study to generate high quality data that can be accurately analyzed to draw clear conclusions.
Comparison of Clinical Trial Application requirement of India, USA and Europe.
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
CDSCO (regulatory affairs)
The Central Drugs Standard Control Organization (CDSCO) is the main regulatory body for pharmaceuticals, medical devices, and clinical trials in India. CDSCO approves new drugs, regulates import/export and manufacturing of drugs, medical devices, and cosmetics. It has various zonal and regional offices. The document outlines CDSCO's role in drug approval process, clinical trials, regulation of cosmetics, and the new Medical Device Rules of 2016.
ANDA Submission.pptx
An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to submit an application to the FDA to obtain approval for generic versions of approved drug products. An ANDA contains data to demonstrate the generic drug is equivalent to the reference listed drug in terms of active ingredients, dosage form, strength, route of administration, quality, and performance characteristics. If approved, the generic drug manufacturer can then produce and market a lower-cost alternative to the public. The ANDA submission must follow the Common Technical Document format and include information in Modules 1-5, with the exception of nonclinical studies. Electronic submissions via eCTD format are now mandatory.
Clinical drug development
The document discusses the various phases of clinical drug development. It describes Phase I trials as initial safety testing in small groups of healthy volunteers. Phase II trials assess safety and efficacy in a small group of patients and explore optimal dosing. Phase III trials demonstrate safety and efficacy in large patient groups. Phase IV trials monitor long-term safety and efficacy after market approval. The document provides details on objectives, patient numbers, study length and progression rates for each phase of clinical drug development.
Snda
The document discusses guidelines for supplemental new drug applications (sNDAs) submitted to the FDA for post-approval changes. It categorizes changes as major, moderate or minor based on their potential impact. Major changes like new manufacturing sites or processes require prior approval. Moderate changes require submission 30 days before distribution or when received by FDA. Minor changes are described in annual reports. The types and levels of data required to support each change category are also outlined.
21 cfr part 50
The document outlines regulations regarding informed consent for biomedical research involving human subjects. It states that informed consent must be obtained from all research participants or their legal guardians. Informed consent documents must include key information such as the study's purpose and procedures, risks and discomforts, benefits, confidentiality protections, and participants' rights to withdraw. Researchers have obligations to fully inform participants and respect their autonomy by ensuring participation is voluntary and without coercion. Special procedures are required for vulnerable populations like children.
ANDA
The document provides information about abbreviated new drug applications (ANDAs), which are designed to allow approval of generic drug products that are equivalent to already approved brand name drugs. An ANDA must show a generic drug is comparable to the reference drug in dosage form, strength, quality and performance. It does not require preclinical and clinical trials but must demonstrate bioequivalence through bioavailability and bioequivalence studies. The ANDA contents and review process are outlined according to the Common Technical Document format in five quality, nonclinical, and clinical modules.
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The document provides information on the New Drug Application (NDA) process for obtaining FDA approval to market a new drug in the United States. It discusses the key components of an NDA, including pre-clinical and clinical research data that demonstrates the drug's safety and efficacy. An NDA must provide detailed information about clinical trials, ingredients, manufacturing, and how the drug behaves in the body. It allows the FDA to determine if the benefits outweigh the risks before a new drug can be legally marketed. The review and approval process takes an average of 5 years from initial discovery to obtain NDA approval.
Prior Approval Supplements (PAS)
This presentation explains in brief the process, types, requirements, and conditions where PAS is needed to submit by drug manufacturers.
New drug approval
The document discusses India's drug regulatory system. The Drug Controller General of India regulates drugs and medical devices in the country to ensure quality, safety and efficacy. New drugs require approval through a New Drug Application process which involves submitting documentation on manufacturing, non-clinical studies, and clinical trials for review. It takes about a year to review an NDA and various forms and fees are involved in the approval and import license application processes.
Hatch waxman act & amendments ppt
The Hatch-Waxman Act established an abbreviated approval pathway for generic drugs that relies on the safety and efficacy evidence of the branded reference drug. It aims to balance incentives for innovation and generic competition. The Act created ANDAs that allow generics to enter the market after patents and exclusivities expire. It also provides the branded drug up to 30 months to litigate patents against Paragraph IV ANDA challenges and restores some patent term lost during regulatory review.
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Comparison of Clinical Trial Application requirement of India, USA and Europe.
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This document provides an overview of Vineeth Kumar Ekbote's lab presentation on new drug applications (NDAs). The presentation covers what an NDA is, the goals and process of an NDA, the forms and contents required in an NDA submission, guidance documents for NDAs, and how NDAs are reviewed and approved by the FDA. The presentation also describes the various sections required in an NDA, including the application summary, chemistry and manufacturing controls, clinical data, and labeling.
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This document discusses new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the US Food and Drug Administration (FDA).
It begins with an overview of the drug development process, then describes the goal and contents of an NDA, including clinical data from trials and information on safety, efficacy, and manufacturing. It also classifies types of NDAs.
The document then discusses ANDAs for generic drugs, noting they do not require new clinical trials but must demonstrate bioequivalence to the brand drug. It covers patent certification requirements for ANDAs.
In conclusion, the key differences between NDAs and ANDAs are summarized, with ANDAs taking less time and money but
New Drug Application [NDA]
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
Drug approval process for US & India
The document compares the drug approval processes in the US and India. In the US, the process involves an Investigational New Drug (IND) application to begin clinical trials, followed by a New Drug Application (NDA) if clinical studies show the drug is safe and effective. In India, companies must apply for permission by submitting data to the Drugs Controller General of India and conduct clinical trials according to guidelines. Both countries have stringent approval standards aimed at safeguarding public health by ensuring drugs are properly tested and manufactured.
Nda
This document provides an overview of the new drug application (NDA) process for obtaining approval to market a new pharmaceutical drug in the United States. It describes the history of NDAs, the application requirements, FDA review process, possible outcomes, and an example of a drug that was initially not approved but later was approved after further use and review in other countries. The overall purpose of the NDA process is to ensure new drugs meet standards of safety and effectiveness before being approved for use and sale.
Preparing an IND Application: CMC
Speaker: Peter Pekos, Dalton Pharma Services. Part of the MaRS Best Practices Series.This session, led by seasoned industry experts, will explore how to effectively set up your pre-clinical POC studies, address pre-clinical safety requirements and issues, and give you an overview of the manufacturing standards required for Phase I studies
More information: http://www.marsdd.com/Events/Event-Calendar/Best-Practices-Series/ind-05132008.html
Overview of the FDA
The FDA has a long history dating back to the early 19th century when organizations were established to set standards for drugs and food. Over time, in response to issues like unsafe drugs killing many Americans, the FDA was created through laws like the 1906 Pure Food and Drug Act. The FDA now regulates food, drugs, medical devices, cosmetics and more to protect public health. It ensures products are safe and properly labeled through inspections and enforcement of cGMP regulations. The FDA works with other domestic and international groups to harmonize standards globally.
Usfda guidelines (1)
The document discusses various guidelines issued by the US Food and Drug Administration (FDA) regarding products regulated by the FDA, such as foods, drugs, medical devices, biologics, cosmetics, and radiation emitting products. It also provides details on FDA guidelines for toxicological studies, clinical trials, manufacturing sterile products, MRI safety, transport temperature maintenance, and clinical trial phases. Guidelines are presented for topics like food packaging, color additives, and maintaining quality control and assurance in accordance with FDA standards.
USFDA
The US Food and Drug Administration (FDA) regulates food, drugs, medical devices, vaccines, and other products in the United States. The FDA is responsible for protecting public health by ensuring the safety and security of these products. It evaluates the safety and efficacy of new drugs and monitors approved drugs for safety issues. The FDA aims to provide accurate science-based information to the public and encourages participation in its regulatory process through public dockets. It works with international authorities like those in India to ensure safety standards for products exported to the US.
International Guidelines and Regulatory Agencies for Toxicity Studies
This document discusses international guidelines and regulatory agencies for toxicity studies. It outlines regulatory agencies like the ICH, OECD, FDA, and WHO that provide guidelines for non-clinical safety testing. The ICH and WHO have produced comprehensive guidelines to assess risks like carcinogenicity, genotoxicity, and reproductive toxicity. The OECD also provides numerous guidelines for specific toxicity study types. The FDA provides guidance documents and draft guidances related to studies like carcinogenicity, immunotoxicology, and photosafety testing.
USFDA
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
New drug approval process
The document summarizes the new drug approval process and development of generic medications. It discusses that new drugs undergo pre-clinical testing in labs and animals, followed by four phases of clinical trials in humans that can take 10-15 years total. If approved, generics can be developed through an abbreviated process by proving bioequivalence to the original. The document stresses the importance of accuracy in prescribing and dispensing drugs due to the risk of errors from similar drug names.
USFDA GUIDLINES
The document provides an overview of the Food and Drug Administration (FDA) in the United States. It discusses that the FDA regulates food, drugs, medical devices, cosmetics and more. It outlines the various centers and offices within the FDA focused on specific areas. It also summarizes some of the key acts and laws that provide the FDA's legal authority. Finally, it discusses cGMP guidelines and regulations under 21 CFR that pharmaceutical manufacturers must follow.
New drug approval ppt
Accredited Consultants Pvt Ltd provides regulatory consulting services for new drug approval in India. The Drug Controller General of India regulates drugs and medical devices through the Central Drugs Standard Control Organization. New drug approval involves submitting a Common Technical Document with information on quality, non-clinical studies, and clinical studies. Approval takes approximately one year and involves fees of Rs. 50,000. After approval, an import license must be obtained through additional documents and fees in order to import the drug. The import license process takes about one month.
Regulatory agencies
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
Usfda
The U.S. Food and Drug Administration (FDA) regulates most foods and medical products. It aims to protect public health by ensuring foods are safe and properly labeled, and that medicines, medical devices and cosmetics are reasonably safe and effective. The FDA oversees a large number of companies and conducts facility inspections to ensure compliance with regulations. It can pursue legal action if regulations are violated.
Pharma regulatory affairs
The document provides information about regulatory affairs and the registration process for pharmaceutical products. It defines key terms like dossier, DMF, CTD/eCTD, and regulatory filing types. It describes the modules of a common technical document for a product registration, including the administrative, summary, quality, non-clinical and clinical sections. Electronic submission using eCTD format is also discussed. Country-specific regulatory agency websites are listed.
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International Guidelines and Regulatory Agencies for Toxicity Studies
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The document provides information about the New Drug Application (NDA) process. The NDA is submitted to the FDA to obtain approval for a new pharmaceutical. It contains clinical and non-clinical data, chemistry information, and manufacturing details. The NDA follows guidelines for formatting and submission. It includes an archival copy that contains all sections and a review copy divided into technical sections bound with colored covers. The document outlines the contents and organization required for each section of the NDA.
NDA- New Drug Application process.pptx
Welcome to our informative slide on the New Drug Application (NDA) - a pivotal milestone in the pharmaceutical world that propels medical innovation to new heights. In this concise presentation, we'll explore the significance of the NDA process and its critical role in bringing life-changing medications to patients in need.
GLOBAL SUBMISSION OF IND, NDA, ANDA.pdf
It's important to note that the specific requirements and processes for INDs, NDAs, and ANDAs may vary between regulatory authorities in different countries. The descriptions provided here are general and based on the common practices in the United States.
Schedule y under drugs and cosmetic act 1945
This document provides information about Schedule Y of the Drugs and Cosmetics Rules 1945 in India, which describes the data required for permission to import or manufacture new drugs. Some key points include: Schedule Y provides requirements for clinical trial phases I-III; responsibilities of sponsors, investigators, and ethics committees; application process and fees; and considerations around human clinical pharmacology trials, draft labeling, and bioequivalence studies.
Sem 2 nda
The document discusses the New Drug Application (NDA) process in the United States. It provides an overview of the history and goal of the NDA, the application format and forms, contents of an NDA, and the FDA approval process. The NDA is submitted to the FDA by drug companies to obtain approval to market a new pharmaceutical product. It contains extensive information on the drug's safety, efficacy, manufacturing and quality controls. The FDA review process involves evaluation of the application by medical and regulatory experts to determine if the drug's benefits outweigh its risks.
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This document provides an overview of regulatory requirements for drugs and pharmaceuticals. It discusses drug regulation by international agreements and regulatory authorities like the FDA. The FDA is organized into centers responsible for drugs, biologics, devices and food. Applications like IND, NDA, ANDA are described which are required for investigational and approved drugs. The new drug approval process is outlined involving pre-clinical and clinical testing taking 10+ years. Key differences between NDA for new drugs and ANDA for generic drugs are summarized.
new drug application
- The document presents information on the New Drug Application (NDA) process required by the FDA to obtain approval to market a new drug product in the United States.
- An NDA provides extensive data from non-clinical and clinical studies to establish the safety, efficacy, and appropriate labeling of the drug. It includes chemistry, manufacturing, and controls information as well as clinical data from Phase I-III trials.
- The goals of an NDA are to determine if the drug's benefits outweigh its risks, if its proposed labeling is appropriate, and if the methods used to manufacture and ensure the drug's quality are adequate.
Nda.keerti
The document discusses the process for submitting a New Drug Application (NDA) to the FDA for approval of a new pharmaceutical. It explains that an NDA contains extensive information on the drug's safety and efficacy established during clinical trials. The FDA assembles review teams to evaluate the NDA across several technical sections including chemistry, non-clinical studies, clinical data, and labeling. The review process involves determining if the application is complete and classifying it for either priority or standard review, with priority given to drugs that would significantly improve treatment options.
New Drug Application (NDA) Filing
The document discusses the New Drug Application (NDA) process required by the FDA to approve new pharmaceutical drugs for sale and marketing in the United States. An NDA provides data from animal and human clinical trials to allow the FDA to determine if the drug is safe, effective and manufactured properly. It includes details on manufacturing, packaging, non-clinical and clinical testing results. If clinical trials confirm the drug's safety and effectiveness, manufacturers can file an NDA to request approval to produce and sell the drug. The NDA review process evaluates whether the drug's risks are outweighed by its benefits and whether labeling and quality controls are adequate.
Global Subbmission of IND, NDA, ANDA
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Dr.Yogannada R
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Dept of Pharmacy Practice
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International drug regulatory affairs
The document discusses international drug regulatory affairs. It provides an overview of the regulatory structures and agencies that govern the pharmaceutical industry. The key regulatory bodies discussed include the FDA in the US, EMEA in Europe, and other agencies in countries like Japan, Australia, Brazil, Nigeria, China, and India. The document also summarizes the various approval processes for new drugs and generics, including requirements for clinical trials, applications, and common technical dossier formats. Common challenges in international regulatory approval are also briefly mentioned.
akshay regulatory seminar 1 productregistrationanddrugapprovalprocessinus.ppt
The document discusses the process for product registration and drug approval in the United States. All new drug products must complete a registration process with the FDA to ensure safety and efficacy. This involves submitting a New Drug Application (NDA) containing clinical and manufacturing data and information. The NDA goes through a review process by FDA teams with expertise in technical areas. The review determines if the drug is approved for marketing in the United States.
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This document discusses distribution records and the Hatch-Waxman Act. It defines distribution records as written data related to the distribution of drug products from manufacturers to distributors. It notes distribution records should include information like product name, strength, recipient details, and quantities. The document also summarizes the key aspects of the Hatch-Waxman Act, including that it established the Abbreviated New Drug Application process for generics and aimed to balance interests of brand and generic drug companies as well as consumers.
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This document discusses the regulatory approval processes for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in the United States. It explains that an NDA contains extensive clinical and non-clinical data submitted by an innovator company to obtain approval for a new drug. An ANDA contains similar data to demonstrate equivalence to an already approved drug for generic versions after patents have expired. The document provides details on the requirements, review processes, and certification pathways for both NDAs and ANDAs.
API, BIOLOGICS,NOVEL,THERAPIES........pptx
The document discusses the regulatory requirements for approval of APIs, biologics, novel drugs, and NDAs. It covers topics such as:
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- Biological products like blood components require registration with the FDA and annual listing of manufactured products.
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NDA Application.pptx
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
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This document provides an overview of regulatory affairs processes for new drugs, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDA). It defines these terms and describes the required contents, format, review process and differences between IND, NDA, and ANDA submissions to regulatory agencies like the FDA. Key points covered include the types of clinical trials and data required for each application and how generic drugs can demonstrate bioequivalence rather than conducting new clinical trials in an ANDA.
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Regulatory Affairs - IND,NDA,ANDA
This document provides an overview of the non-clinical development process and global submission of Investigational New Drug Applications (IND), New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDA). It discusses the purpose and requirements for IND, NDA, and ANDA submissions to regulatory agencies globally. Key points include the format and content of IND, NDA, and ANDA submissions, as well as criteria for IND applications and the review process by regulatory agencies. The goal is to obtain approval to conduct clinical trials for an investigational drug or market a new pharmaceutical product.
global submission of ANDA .pptx
This document discusses the global submission process for Abbreviated New Drug Applications (ANDAs), which are required for generic drug approval by the FDA. Key points include: ANDAs do not require new clinical trials, but must demonstrate bioequivalence to the branded drug; various regulations govern the ANDA process; ANDAs include application forms, labeling, manufacturing details, and patent certifications; there are exclusivity periods for innovator drugs and 180 days of exclusivity for the first generic challenger of a patent.
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The document discusses pharmaceutical marketing practices in India and the development of a Uniform Code of Pharmaceutical Marketing Practices (UCPMP). It notes that while the UCPMP aims to standardize ethical practices, some remain skeptical of its effectiveness without strict enforcement. Concerns have been raised about the influence of pharmaceutical company promotions on doctor prescribing habits. The UCPMP framework outlines principles for ethical product promotion, prohibiting gifts to influence prescribing, and requiring transparency around expenditures.
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The document discusses various methods for analyzing carbohydrates, including qualitative and quantitative tests. It begins by classifying carbohydrates based on carbon atom count, terminal functional groups, number of sugar subunits, and other characteristics. Several common qualitative carbohydrate tests are then described in detail, including the Molisch test, Benedict's test, Barfoed's test, and others. The tests allow identification of carbohydrates by reaction color or formation of characteristic precipitates. The document also mentions quantitative carbohydrate analysis using liquid chromatography-mass spectrometry and biochemical testing specifically for glucose.
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The document discusses the history and importance of chocolate in human civilization. It notes that chocolate originated in Mesoamerica over 3000 years ago and was prized by the Aztecs and Mayans for its taste. Cocoa beans were used as currency and their cultivation was tightly regulated. The document stresses that chocolate became widely popular in Europe only after it was introduced from the Americas in the 16th century.
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The document discusses design for manufacturing and assembly (DFMA) techniques. It defines design for manufacturing (DFM) as optimizing the manufacturing process to minimize part production costs. Design for assembly (DFA) is defined as optimizing the assembly process to minimize assembly costs. The key differences and similarities between DFM and DFA are explained. Some principles of DFMA include reducing the number of parts, using common features and axes, and utilizing standards. The overall goal of DFMA is to design products that can be easily and cost-effectively manufactured and assembled.
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nda
- 2. Since 1938 in U.S. A vehicle for approval of New Drugs
- 3. NDA is a … • A formal proposal of Sponsor to the FDA for the granting the Marketing & Sale Approval of their new pharmaceutical. • A narrative of the Drug – Ingredients – Manufacture, processing, packaging – Non clinical data – Clinical data – P’cokinetics & dynamics
- 4. Why NDA??? • Safety & Efficacy, risk benefit ratio • Proposed labeling (Package Insert)scrutinized • Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.
- 5. 21CFR part 314 • Sub parts A to I • subpart A: General Provisions – Scope, Purpose & Definitions
- 6. Subpart B: Applications Content and format of an application. Notice of certification of invalidity or noninfringement of a patent. Submission of patent information. Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug. Pediatric use information. Amendments to an unapproved application. Withdrawal by the applicant of an unapproved application. Supplements and other changes to an approved application. Procedures for submission of a supplement to an approved application. Change in ownership of an application. Postmarketing reporting of adverse drug experiences. Other postmarketing reports. Waivers.
- 7. Contents & Format Three copies of the application are required: 1. An archival copy, 2. A review copy, and 3. A field copy.
- 8. Contents & Format An application form (Form FDA-356h) An index, A summary, Five or six technical sections, Case report tabulations of patient data, case report forms, Drug samples, and labeling, including, if applicable, Any Medication Guide required
- 9. FDA Review • Review period -180 days • Three possible outcomes from FDA- – Approval Letter – Approvable Letter – Not Approvable Letter
- 10. Prescription Drug User Fee Act (PDUFA) • On November 21, 1997, The President signed the Food and Drug Administration Modernization Act of 1997. This legislation includes authorization for FDA to continue to collect three types of user fees from applicants who submit certain new drug and biological product applications.
- 11. NDA in India Form 44
- 13. Requirements for the Drug Approval in India Has five Modules 1. Module I: Administrative/Legal Information 2. Module II: Summaries 3. Module III: Quality information (Chemical, pharmaceutical and biological) 4. Module IV: Non-clinical information 5. Module V: Clinical information
- 14. Application Review Period Remains the same as that of USFDA ____ days
- 15. Thank You Any Questions to ask???? Or else drop them in this mail id. kavaderima@gmail.com
Editor's Notes
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