This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
Investigational new drug ,orange book,understanding on 505(b) (2) applicationsswrk
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.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of documentation like the common technical document by committees like CHMP and ultimately decisions made by the European Commission.
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.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
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.
Ind (investigational new drug application) and ndaswati2084
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes for bringing new drugs to market. It describes how an IND must be submitted to the FDA to test an experimental drug in humans, and outlines the types of INDs, content requirements, and review process. An NDA contains extensive clinical trial data and is required for FDA approval to commercially market a new drug. The lengthy and costly process from initial research to marketing approval averages 15 years and $900 million per new drug.
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.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
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.
Investigational new drug ,orange book,understanding on 505(b) (2) applicationsswrk
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.
The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of documentation like the common technical document by committees like CHMP and ultimately decisions made by the European Commission.
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.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
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.
Ind (investigational new drug application) and ndaswati2084
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes for bringing new drugs to market. It describes how an IND must be submitted to the FDA to test an experimental drug in humans, and outlines the types of INDs, content requirements, and review process. An NDA contains extensive clinical trial data and is required for FDA approval to commercially market a new drug. The lengthy and costly process from initial research to marketing approval averages 15 years and $900 million per new drug.
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.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
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.
Preparation of Clinical Trial Protocol of India.Aakashdeep Raval
The document provides information on clinical trial protocols in India. It discusses the purpose of clinical trials and phases of clinical trials from Phase 0 to Phase 4. It explains that the clinical trial protocol is a document that states the background, objectives, design, methodology and statistical considerations of a clinical trial. The protocol describes inclusion/exclusion criteria, assessments of efficacy and safety, data management, quality control and other key elements to ensure proper conduct of the clinical trial. An effective clinical trial protocol provides all the necessary details to guide researchers in safely and ethically evaluating a medical treatment.
- 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.
Investigational products are pharmaceutical forms being tested in clinical trials. They must be manufactured and handled according to good manufacturing practices and used according to the trial protocol. The sponsor is responsible for supplying the investigational product and ensuring proper manufacturing, packaging, labeling, coding, and storage conditions. The investigator is responsible for proper receipt, inventory, storage, dispensing, return of unused product, and final accountability of the investigational product at the trial site. Monitors verify that investigational products are properly supplied, stored, dispensed, and returned. Pharmacies play an important role in ensuring investigational products are appropriately managed throughout the clinical trial.
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
Clinical Research Regulation in European Union ShantanuThakre3
The document discusses clinical research regulations in the European Union. It provides information on the aim of the European Medicines Agency (EMA) in regulating clinical trials to protect subjects' rights and safety. It describes the EMA's role in ensuring good clinical practice standards across the European Economic Area. It also summarizes key points of the new Clinical Trials Regulation, including requirements for authorization, informed consent, and conducting trials on vulnerable groups. Finally, it discusses the Clinical Trials Information System that will support application and oversight of trials under the new Regulation.
An Investigational New Drug (IND) application allows a sponsor to lawfully use an investigational drug for clinical investigation purposes. It provides information on preclinical testing, clinical protocols, manufacturing, and investigator qualifications to ensure subject safety. An IND is required for clinical studies intended to support a new indication, change in dosage/administration, or different patient population. It exempts the sponsor from prohibitions on shipping unapproved drugs and facilitates three phases of clinical trials to evaluate safety and efficacy.
regulatory requirnment and approval procedure for drugs and cosmetics, medica...sandeep bansal
This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.
The document discusses an Investigational New Drug Application (IND), which is a submission to the FDA requesting permission to study an experimental drug in clinical trials. An IND provides safety data from animal studies and details of the proposed clinical trials. It includes information on the drug's chemistry, manufacturing, pharmacology and any previous human experience. The IND process allows a drug to move through preclinical and clinical testing in humans while being monitored by the FDA to ensure the protection of clinical trial subjects.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
This document outlines the regulations for investigational new drugs as described in Part 312 of Title 21 of the Code of Federal Regulations. It discusses the requirements for investigational new drug applications (INDs), including the content that must be submitted in an IND. Key points covered include the phases of clinical investigation for a new drug, safety reporting requirements for INDs, protocols for amending an IND, and the conditions under which FDA can place a clinical hold, terminate an IND, or change a drug's status. The purpose is to ensure new drugs are properly evaluated for safety and effectiveness before being approved for marketing.
The document discusses the key aspects of an Investigational New Drug (IND) application submitted to the FDA to request permission to conduct clinical trials of an unapproved drug. An IND application contains information on the drug's chemistry, manufacturing, pharmacological and toxicological effects, clinical protocol, and investigators brochure. It allows the FDA to ensure the risks to human subjects are reasonable. The FDA reviews INDs within 30 days to determine if a clinical hold is needed before trials can begin. Annual reports updating trial progress are also required.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
This document provides an overview of pharmaceutical regulations for drug approval in the US, EU, and India. It discusses the drug approval processes and requirements in each region, including the types of applications submitted (e.g. ANDA, NDA), necessary documentation, evaluation timelines, and guidelines followed (e.g. ICH). It also compares some key parameters of the regulatory frameworks like bioequivalence study designs, criteria, and pharmacokinetic measures assessed between the different jurisdictions.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
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:
Regulatory aspects of orphan drugs devolpmentsJITHIN K JOY
This document discusses regulatory aspects of orphan drugs and developments. It begins by defining orphan diseases and the need for orphan drug regulation to incentivize development of treatments for rare conditions. It describes orphan drug regulations in various countries like the US, Japan, Australia and challenges in developing orphan drugs. In India, around 6000-8000 rare diseases have been identified but many lack treatments. The document calls for India to introduce its own orphan drug act to define rare diseases, provide incentives for research and improve access to existing orphan drugs.
This document outlines the requirements and contents of an Investigator's Brochure (IB), which is a comprehensive document summarizing clinical and non-clinical data on an investigational product. The IB includes summaries of pharmacology, toxicology, safety and efficacy data from animal and human studies. It also provides guidance to investigators on monitoring patients and outlines a product's risks and important trial precautions. The IB's purpose is to inform investigators of the investigational product's properties to protect patient safety in clinical trials. It is prepared by the sponsor and provided to investigators to review before trials begin.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
The document summarizes the process for obtaining an Investigational New Drug Application (IND) from the FDA to conduct clinical trials of an experimental drug. It outlines what is included in an IND submission such as preclinical data, clinical protocols, manufacturing information, and previous human experience. It also describes the FDA review process and requirements for annual reports during the clinical trial period. The overall goal of an IND is to demonstrate an experimental drug's safety for initial testing in humans while obtaining approval to conduct clinical research.
The document discusses the Investigational New Drug (IND) application process with the FDA. An IND application allows a company to ship an experimental drug across state lines and begin clinical trials. It must include preclinical data to show the drug is safe for initial human use as well as protocols for proposed studies. The FDA reviews the IND for 30 days before clinical trials may begin to ensure subject safety. The overall goal of an IND is to facilitate testing of new drugs while protecting clinical trial participants.
Preparation of Clinical Trial Protocol of India.Aakashdeep Raval
The document provides information on clinical trial protocols in India. It discusses the purpose of clinical trials and phases of clinical trials from Phase 0 to Phase 4. It explains that the clinical trial protocol is a document that states the background, objectives, design, methodology and statistical considerations of a clinical trial. The protocol describes inclusion/exclusion criteria, assessments of efficacy and safety, data management, quality control and other key elements to ensure proper conduct of the clinical trial. An effective clinical trial protocol provides all the necessary details to guide researchers in safely and ethically evaluating a medical treatment.
- 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.
Investigational products are pharmaceutical forms being tested in clinical trials. They must be manufactured and handled according to good manufacturing practices and used according to the trial protocol. The sponsor is responsible for supplying the investigational product and ensuring proper manufacturing, packaging, labeling, coding, and storage conditions. The investigator is responsible for proper receipt, inventory, storage, dispensing, return of unused product, and final accountability of the investigational product at the trial site. Monitors verify that investigational products are properly supplied, stored, dispensed, and returned. Pharmacies play an important role in ensuring investigational products are appropriately managed throughout the clinical trial.
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
Clinical Research Regulation in European Union ShantanuThakre3
The document discusses clinical research regulations in the European Union. It provides information on the aim of the European Medicines Agency (EMA) in regulating clinical trials to protect subjects' rights and safety. It describes the EMA's role in ensuring good clinical practice standards across the European Economic Area. It also summarizes key points of the new Clinical Trials Regulation, including requirements for authorization, informed consent, and conducting trials on vulnerable groups. Finally, it discusses the Clinical Trials Information System that will support application and oversight of trials under the new Regulation.
An Investigational New Drug (IND) application allows a sponsor to lawfully use an investigational drug for clinical investigation purposes. It provides information on preclinical testing, clinical protocols, manufacturing, and investigator qualifications to ensure subject safety. An IND is required for clinical studies intended to support a new indication, change in dosage/administration, or different patient population. It exempts the sponsor from prohibitions on shipping unapproved drugs and facilitates three phases of clinical trials to evaluate safety and efficacy.
regulatory requirnment and approval procedure for drugs and cosmetics, medica...sandeep bansal
This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.
The document discusses an Investigational New Drug Application (IND), which is a submission to the FDA requesting permission to study an experimental drug in clinical trials. An IND provides safety data from animal studies and details of the proposed clinical trials. It includes information on the drug's chemistry, manufacturing, pharmacology and any previous human experience. The IND process allows a drug to move through preclinical and clinical testing in humans while being monitored by the FDA to ensure the protection of clinical trial subjects.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
This document outlines the regulations for investigational new drugs as described in Part 312 of Title 21 of the Code of Federal Regulations. It discusses the requirements for investigational new drug applications (INDs), including the content that must be submitted in an IND. Key points covered include the phases of clinical investigation for a new drug, safety reporting requirements for INDs, protocols for amending an IND, and the conditions under which FDA can place a clinical hold, terminate an IND, or change a drug's status. The purpose is to ensure new drugs are properly evaluated for safety and effectiveness before being approved for marketing.
The document discusses the key aspects of an Investigational New Drug (IND) application submitted to the FDA to request permission to conduct clinical trials of an unapproved drug. An IND application contains information on the drug's chemistry, manufacturing, pharmacological and toxicological effects, clinical protocol, and investigators brochure. It allows the FDA to ensure the risks to human subjects are reasonable. The FDA reviews INDs within 30 days to determine if a clinical hold is needed before trials can begin. Annual reports updating trial progress are also required.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
This document provides an overview of pharmaceutical regulations for drug approval in the US, EU, and India. It discusses the drug approval processes and requirements in each region, including the types of applications submitted (e.g. ANDA, NDA), necessary documentation, evaluation timelines, and guidelines followed (e.g. ICH). It also compares some key parameters of the regulatory frameworks like bioequivalence study designs, criteria, and pharmacokinetic measures assessed between the different jurisdictions.
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
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:
Regulatory aspects of orphan drugs devolpmentsJITHIN K JOY
This document discusses regulatory aspects of orphan drugs and developments. It begins by defining orphan diseases and the need for orphan drug regulation to incentivize development of treatments for rare conditions. It describes orphan drug regulations in various countries like the US, Japan, Australia and challenges in developing orphan drugs. In India, around 6000-8000 rare diseases have been identified but many lack treatments. The document calls for India to introduce its own orphan drug act to define rare diseases, provide incentives for research and improve access to existing orphan drugs.
This document outlines the requirements and contents of an Investigator's Brochure (IB), which is a comprehensive document summarizing clinical and non-clinical data on an investigational product. The IB includes summaries of pharmacology, toxicology, safety and efficacy data from animal and human studies. It also provides guidance to investigators on monitoring patients and outlines a product's risks and important trial precautions. The IB's purpose is to inform investigators of the investigational product's properties to protect patient safety in clinical trials. It is prepared by the sponsor and provided to investigators to review before trials begin.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
The document summarizes the process for obtaining an Investigational New Drug Application (IND) from the FDA to conduct clinical trials of an experimental drug. It outlines what is included in an IND submission such as preclinical data, clinical protocols, manufacturing information, and previous human experience. It also describes the FDA review process and requirements for annual reports during the clinical trial period. The overall goal of an IND is to demonstrate an experimental drug's safety for initial testing in humans while obtaining approval to conduct clinical research.
The document discusses the Investigational New Drug (IND) application process with the FDA. An IND application allows a company to ship an experimental drug across state lines and begin clinical trials. It must include preclinical data to show the drug is safe for initial human use as well as protocols for proposed studies. The FDA reviews the IND for 30 days before clinical trials may begin to ensure subject safety. The overall goal of an IND is to facilitate testing of new drugs while protecting clinical trial participants.
The document discusses the purpose and requirements of an Investigational New Drug (IND) application submitted to the FDA. An IND allows a company to ship an experimental drug and conduct clinical trials in humans. It provides safety data and details of planned trials for FDA review to ensure risks are minimized for subjects. A complete IND includes chemistry, manufacturing, pharmacology, protocols and other application materials for FDA evaluation before trials may begin.
The new drug approval process involves several phases of laboratory and clinical testing that can take over a decade and cost hundreds of millions of dollars. Only about 1 in 1000 compounds that enter pre-clinical testing are approved for human testing. After pre-clinical animal testing, companies submit an Investigational New Drug (IND) application to the FDA to request permission for human clinical trials. If approved, the drug then enters three phases of clinical trials involving several hundred to thousands of human subjects to evaluate safety, efficacy, and proper dosing. If phase 3 trials are successful, companies submit a New Drug Application (NDA) to the FDA for review and potential approval allowing marketing and post-market safety surveillance.
This document discusses the requirements for an investigational new drug (IND) application. An IND is required to initiate clinical trials of an unapproved drug and must contain information on animal studies, manufacturing, and clinical trial protocols. The core battery of safety pharmacology studies evaluates effects on major organ systems like the cardiovascular, central nervous, and respiratory systems. These studies are designed to identify potential adverse effects and safety risks before human clinical trials.
The document discusses regulatory requirements for non-clinical drug development, including guidelines from the European Medicines Agency. It describes the types of non-clinical studies done in silico, in vitro, and in vivo to determine efficacy, safety, delivery methods, and manufacturing viability before clinical trials. Key submissions to regulators include the Investigational New Drug Application, New Drug Application, and Abbreviated New Drug Application.
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.
Investigational New Drug Application enabling studies.pptxNikitaBankoti2
The document provides information on Investigational New Drug (IND) applications. It defines an IND as a submission to the FDA requesting permission to study an investigational drug product in humans. Key points include:
- An IND application contains preclinical and clinical data to demonstrate it is reasonably safe to study the drug in humans.
- It allows the sponsor to initiate and conduct clinical trials of the investigational drug.
- The IND application process helps ensure the safety of clinical trial subjects and that clinical studies will yield valid results to determine a drug's safety and effectiveness.
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.
This document provides information about Investigational New Drug (IND) applications submitted to the FDA to request permission to study an unapproved drug in clinical trials. It discusses the types of INDs (investigational use, emergency use, treatment use), contents required in an IND submission, and circumstances where an IND is or is not required. The key purposes of an IND are to provide safety data from animal studies to begin human trials and to describe the initial proposed clinical study for FDA review before starting research.
The document provides information on Investigational New Drug (IND) enabling studies and the IND application process. Some key points:
- An IND application is required to ship an experimental drug across state lines for clinical trials before marketing approval. The FDA reviews the IND for safety.
- An IND application contains information on animal studies, chemistry/manufacturing, and clinical trial protocols. It must demonstrate the drug is reasonably safe for initial human testing.
- An IND application must follow specific guidelines, including summaries of pharmacology/toxicology studies, chemistry/manufacturing details, clinical protocols, and responsibilities of investigators and sponsors. It allows the drug to enter Phase I clinical trials upon
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
Non-clinical contract research organizations (CROs) have become an integral part of drug discovery and development to support sponsors research needs, expedite timelines and provide an extension of technical and scientific support.
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes required by the FDA to develop and approve new drugs. It describes how developing a new drug takes 15 years and over $900 million on average. The IND allows testing of new drugs in humans and provides safety data, while the NDA provides all clinical trial data for the FDA to determine if the drug is safe and effective for approval. Both the IND and NDA are lengthy applications that require extensive non-clinical and clinical data to gain FDA approval to market a new prescription drug.
The document provides an overview of the drug development and approval process at the US Food and Drug Administration (FDA). It describes the FDA's structure and responsibilities in regulating drugs, medical devices, food, cosmetics, and other products. The key stages of drug development include drug discovery, pre-clinical testing, clinical trials (Phase I-III), and new drug application. FDA approval is required through this rigorous process to ensure safety and effectiveness before a new drug can reach consumers.
An Investigational New Drug (IND) application allows a sponsor to legally test an unapproved or investigational drug in clinical trials. The sponsor must provide preclinical data on pharmacology, toxicology and manufacturing to show the drug is reasonably safe for initial human testing. After submitting an IND, clinical trials can begin if FDA does not disapprove the application within 30 days. The IND application process and clinical trials are regulated to ensure data quality and subject safety.
The document discusses non-clinical studies that are conducted before testing new drugs in humans. Non-clinical studies, also called pre-clinical studies, evaluate safety, efficacy, and therapeutic effects in animals, computer models, and lab settings. They aim to answer questions about safety, quality, side effects, and how the drug works in the body before starting clinical trials. After successful non-clinical studies, sponsors can submit an Investigational New Drug (IND) application to the FDA to request permission to test the drug in human clinical trials. The IND process and New Drug Application (NDA) process are also summarized.
This document summarizes key aspects of non-clinical drug development. It discusses how non-clinical studies are performed in silico, in vitro, and in vivo to assess safety, efficacy, pharmacokinetics, and manufacturing viability before human clinical trials. It also describes the Investigational New Drug application process which is required to begin clinical trials in humans, and provides an overview of the New Drug Application submitted for marketing approval. The document concludes by outlining the contents of an Investigational Medicinal Products Dossier which forms the basis for approval of multinational clinical trials in the European Union.
This document discusses the qualification of Fourier transform infrared spectroscopy (FTIR). It begins with an introduction to FTIR, describing how it works and its advantages over dispersive spectroscopy. It then discusses instrumentation components like radiation sources, interferometers, and detectors. The document outlines various inspection methods used to qualify FTIR like wave number precision, 0% transmittance, linearity, and repeatability. It provides details on performing and validating the qualification using a validation program and stored reference data. Finally, it lists some applications of FTIR in pharmaceutical analysis like identification, structure determination, and reaction studies.
The document provides details on qualifying a gas chromatography (GC) instrument. It discusses the four levels of qualification: design qualification, installation qualification, operational qualification, and performance qualification. Specific tests and acceptance criteria are proposed to qualify different modules of the GC like the inlet system, oven, and flame ionization detector. These include tests to check parameters like injector leak, temperature accuracy and stability, peak area precision, retention time repeatability, and more. The document aims to help laboratories properly qualify their GC instruments and ensure they are functioning as intended for use in pharmaceutical analysis applications.
This presentation discusses impurities in residual solvents and provides guidelines for their classification and acceptable limits. It summarizes the ICH Q3C guideline, which classifies residual solvents into four categories based on toxicity. Class 1 solvents are to be avoided, while Class 2 solvents should be limited and Class 3 solvents have low toxic potential but levels should not exceed recommendations. Analytical methods for determining residual solvent levels are also covered. The guideline aims to recommend safe amounts of residual solvents in pharmaceuticals to protect patient safety.
This document describes methods for determining pesticide residues in foods. It discusses extracting pesticides from grains, fruits, vegetables, and milk using solvents like acetone and dichloromethane. The extracts are then cleaned up using chromatographic columns packed with materials like celite, carbon, and florisil. The cleaned extracts are analyzed using gas chromatography with detectors like FPD. The document provides operating conditions for GC and equations for calculating pesticide residue levels in foods based on peak heights. It also references several sources for additional information on pesticide residue analysis techniques.
The document presents information on the analysis of pesticides. It discusses organophosphorous pesticide analysis and organochlorine pesticide analysis. For organochlorine pesticide analysis, it describes the sodium biphenyl reduction method which involves decomposing organic halogen compounds using sodium biphenyl and titrating the liberated halide ion. It also provides an example of using this method to analyze endrin, including the reagents, preparation of the sample, and determination steps.
The document describes a human anti-hemophilic vaccine produced from human plasma. It discusses the collection of plasma from healthy donors, the production process which involves precipitation and purification using column chromatography, and the assay used to determine potency by comparing clotting times. The production involves testing donor blood to ensure safety, separating plasma from blood within 12 hours, and using an ion exchange column to capture factor VIII. The purified fraction is tested for activity and virus inactivation is performed before lyophilization.
Thank you for the detailed presentation on electrophoresis. I appreciate you taking the time to explain the key concepts and techniques. Please let me know if you have any other questions.
Venom from snakes and other animals is stored in specialized glands. Snake venom in particular contains over 20 different toxic proteins and enzymes. Antivenom is produced by immunizing animals like horses with snake venom to produce antibodies, which are then purified and used to treat envenomings. Biological tests and assays involve injecting mixtures of venom and antivenom into mice to determine the neutralizing capacity and potency of the antivenom in mouse units per milligram. These tests are important for standardizing antivenom production and ensuring its effectiveness.
This document provides information about the microbial assay of vitamins, specifically vitamin B12. It discusses the underlying principles of microbial assays which measure the ability of test organisms to utilize substances being assayed under proper nutritional conditions. The response is proportional to the amount added. Methods described include the cylinder-plate method using diffusion and the turbidimetric tube assay method measuring inhibition of growth. The document then details the specific procedure for assaying vitamin B12 using Lactobacillus leichmannii, including preparation of reagents, media, and inoculum.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Cell Therapy Expansion and Challenges in Autoimmune Disease
Investigational new drug
1. SUBMITTED BY-
SANTHOSH KUMAR T S
M.PHARM
1ST YEAR
PRESENTATION ON :
INVESTIGATIONAL NEW DRUG [IND]
KARNATAKA COLLEGE OF PHARMACY
BANGALORE
FACILITATED TO-
Dr. C. SREEDHAR SIR
HEAD OF THE DEPARTMENT
(PH. ANALYSIS)
3. PHARMACEUTICALS MAY MOVE ACROSS STATE LINES DURING
TWO STAGES OF HUMAN USE
• Research prior to “approval”
e.g., New Drug application
– Requires research permit: New Drug Exemption (IND)
e.g., Investigational application
• Marketing after “approval”
– Requires marketing permit: Application (NDA)
4. PRE-CLINICAL TESTING
• When new drugs show promise in lab testing, studies
are designed to evaluate them further.
• These studies in animals are referred to as “pre-clinical
studies.”
5. PRE-CLINICAL TESTING
• Pre-clinical studies help establish boundaries for safe use of the treatment
if/when human studies begin. (Animal Models :- to test drugs & side effects)
• Many new drugs and treatments are abandoned at this step because they are
proven unsafe.
6. CLINICAL RESEARCH AND DEVELOPMENT
• The application to the FDA to request permission to begin human testing is
called an Investigational New Drug application, or IND.
• The IND permits the use of an investigational new drug for the sole purpose of
conducting clinical trials.
7. DRUG-DISCOVERY, DEVELOPMENT & ITS APPROVAL
It takes 12-15 years on an average for an experimental drug to travel from the lab to the patients. Only 5 in
5000 compounds that enter the pre-clinical testing stage, make it to the human-testing stage. One of these 5
tested on people is approved.
Discovery/
Pre-Clinical
Testing
Phase I Phase II Phase III FDA Phase IV
Years 5 - 6.5
File
IND
at FDA
1.5 2 2.5
File
NDA
at FDA
1.5- 2
Test
Population
Laboratory &
Animal Studies
20 to 100
healthy
volunteers
100 to 500
patient
volunteers
1000 to 5000
patient
volunteers
Review
&
Proposal
Process
Additional
Post-
Marketing
testing
required
by FDAPurpose
Assess safety,
biological activity
& formulation
Determine
safety &
dosage
Evaluate
effectiveness,
look for side-
effects
Confirm
effectiveness
monitor
adverse effects
from long-time
use
Success
Rate
5000
compounds
evaluated
5 EnterTrials
1
Approved
8. INVESTIGATIONAL NEW DRUGAPPLICATION (IND)
• An Investigation New Drug Application (IND) is a submission to Food & Drug
Administration (FDA) requesting permission to initiate the study of New drug
product
• In many ways, the investigational new drug (IND) application is the result of a
successful preclinical development program.
• The IND is also the vehicle through which a sponsor advances to the next stage of
drug development known as clinical trials (human trials).
• During a new drug's early preclinical development, the sponsor's primary goal is to
determine if the product is reasonably safe for initial use in humans, and if the
compound exhibits pharmacological activity that justifies commercial development.
• The standard for approval is evidence of safety and efficacy
• The IND exemption is granted for purposes of clinical investigation (research)
9. IMPORTANCE OF THE IND
• Affirms a body of knowledge about the manufacturing, pharmacology, and
toxicology of the drug to support its use in human testing
• Requires that the clinical investigation(s) be performed in accordance with Good
Clinical Practice (GCP)
• Provides an additional level of protection through FDA oversight
10. • There are three IND types:
Investigator IND
Emergency Use IND
Treatment IND
• There are two IND categories:
Commercial (Ultimate goal is to achieve marketing approval for new product)
Research (non-commercial)
TYPES OF IND
11. INVESTIGATOR/SPONSOR IND
• 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 Research IND is to be submitted for proposed study of
Unapproved drug
Approved product for
• New indication
• New patient population
• Motivation is not necessarily commercial in nature.
12. EMERGENCY USE IND
• It allows the FDA to authorize use of an experimental drug in an emergency
situation that does not allow time for submission of an IND in accordance
with 21CFR , Sec. 312.23 or Sec. 312.34
• It is also used for patients:
who do not meet the criteria of an existing study protocol
or if an approved study protocol does not exist.
Reserved for life-threatening situations
No standard acceptable treatment is available
13. TREATMENT IND
• The treatment IND [21 CFR 312.34 and 312.35] is a mechanism for providing eligible
subjects with investigational drugs for the treatment of serious and life-threatening
illnesses for which there are no satisfactory alternative treatments.
• Experimental drugs showing promise in clinical testing-safety and efficacy.
• After completion of Phase I and II
Used for the treatment of serious or life threatening conditions
• No alternate treatments available
• AIDS, Cancer
Made available while final clinical testing is completed and reviewed by the FDA
Reduce reluctance of people to participate in expanded drug access programs
14. WHO CAN APPLY FOR IND????
• Applicant (Drug Sponsor)
• An applicant, or drug sponsor, is the person or entity who
assumes responsibility for the marketing of a new drug, including
responsibility for compliance with applicable provisions of the
Federal Food, Drug and Cosmetic Act and related regulations.
• The "sponsor" Is usually An individual, partnership, corporation,
Government agency, manufacturer or scientific institution.
15. • The IND application provides FDA with data necessary to decide whether the new drug
& the proposed Clinical trial pose a reasonable risk to human subjects participating in
the study.
• The IND application allows the company to initiate & conduct the clinical studies of
their new drug Product.
• The safety of the Clinical trial Subjects is always the primary concern of FDA.
• When preparing the IND & throughout the Drug development process the primary
goal of the Sponsor should be to demonstrate to the FDA that the
-new drug
-proposed trial
-entire clinical development plan described in the IND is designed to minimize the risk
to the trial subjects.
16. WHEN DO WE NEED AN IND?
• An IND would be required to conduct a Clinical trial if the drug is –
-A new chemical entity not approved for the indication under
Investigation in the new dosage form.
- being administered at the new dosage level.
-In combination with another drug & the combination is not approved.
17. CONTENT AND FORMAT OF THE IND
21 CFR 312.23
• All available information impacting on SAFETY!
• Animal studies
• Pharmacology (ADME)( Absorption, Distribution, Metabolism, Elimination )
• Toxicology (Lethal Dose, Short, long, genotoxicity etc)
• Previous clinical experience
• Foreign and domestic sources
• Scientific literature
18. • Overall plan of study for next year (minimum)
• Proposed protocols with justification
• Patient Inclusion & Exclusion criteria
• Method of patient selection to prevent bias
• Identification & qualifications of investigators & sub-investigators
• Assurances of investigator supervision
• Assurances sponsor monitor
• Identification of key responsible individuals
19. GENERAL PRINCILPLE OF IND
• Toassure safety and rights of the subject.
• To assure Scientific quality of
investigation
the
will yield data Capable of
statutory Standards for marketingmeeting
approval
• The central Focus should be on general
investigational plan & protocol which should be supported by
additional information including animal toxicological studies
20. REQUIREMENTS OF AN IND
• A sponsor shall submit an IND to FDA who intends to conduct a clinical
investigation.
• Investigation is not supposed to begin without prior written
authorization of FDA
PHASES OF INVESTIGATION
• Phase 1 -- ADME (20- 80)healthy subjects
• Phase 2 – effectiveness in particular indication (several hundred patients)
• Phase 3 – safety andeffectiveness ( 100- 1000) subjects.
21. FORMAT OF INDA
1. Cover sheet (FORM FDA1571)
2. Table of contents
3. Introductory statement and a general investigational plan
4. Investigators brochure
5. Protocols
6. Chemistry , manufacturing and control information
7. Pharmacology and Toxicology information
8. Previous human experience with the investigational drug
9. Other relevant information like no of IND submissions,
Number of copies to be submitted (1 + 2)
10. Protocol amendments, any changes in the protocol.
22. o Name, address, telephone of sponsor
o Identification of phases
o Commitment not to begin CT until IND approval
o Commitment by IRB- Form 56
o Commitment for conducting CT- accordance with regulations
o Name, title – Monitor
o Name, title – person(s) for reviewing
o Name, Address of CRO, if any
o Signature of sponsor
1. Cover sheet (FORM FDA 1571)
23. 2.TABLE OF CONTENTS
- Comprehensive listing of contents of IND application broken
in volumes & page number.
- TOC should include details of -
sections, appendices, attachments, reports & other reference
material
- A well drafted TOC will facilitate the task of review & decrease
the review time.
24. 3.GENERALINVESTIONALPLAN
a brief 3 to 4 pages note on –
- the investigational product
- Sponsors’ Investigationalplan
- Goal of the section is to –
- to provide brief description of the drug
- layout development plan of the drug
25. 4.INVESTIGATORS BROCHURE
- key document provided to each Investigator & IRB at each of the
Clinical site.
- includes-
ALL ABOUT THEINVESTIGATIONAL DRUG
- IB is a living document & must be updated by the Sponsor.
26. 5.PROTOCOLS
Describes how the Clinical trial would be conducted.
- It describes – the objective of the study
- the trial design
- how subjects would be selected
- how the trail is to be conducted.
- ALL ABOUT THAT HOW THE STUDY WOULD BE CONDUCTED??
27. 6.CHEMISTRY , MANUFACTURING AND CONTROL
INFORMATION
• CMC information-
-sufficient detail on QUALITY, IDENITY, PURITY & POTENCY
of the drug product.
- manufactured in conformance with cGMP.
- CMC section includes the following –
1. Introduction CMC
2. Summary
3. information of Placebo, if any
4. Proposed clinical label
5. categorical exclusion of any environmental assessment
28. 7.PHARMACOLOGY AND TOXICOLOGY INFORMATION
• PHARMACOLOGY & TOXICOLOGYDATA –
- Non-clinical safety data that sponsor generated to prove that the IP is safe
for clinicalstudy.
- The amount & type of data depends on- class of new drug,
duration of proposed, clinical trial patient population that will be
exposed during the trial.
29. 8.PREVIOUS HUMAN EXPERIENCE WITH THE
INVESTIGATIONAL DRUG
integrated summary report of any human studies conducted on the investigational
drug
Relevant to the safety of the investigations to be done – Pharmakokinetic studies,
Pharmacodynamic studies observed adverse event profile
30. 9. OTHER RELEVANT INFORMATION LIKE NUMBER OF IND
SUBMISSIONS,
No of copies to be submitted (1 + 2)
• ADDITIONAL INFORMATION – special topics
drug dependence & abuse potential Radioactive drugs
pediatric population & other information
• OTHER RELEVANT INFORMATION –
Information specifically requested by FDA
• Financial disclosure information from each Investigator
& sub Investigator.
• Drug master File ( DMF)
• Reports or journal articles
• The IND application is always submitted in 1+ 2 format i.e. 1
original & 2 additional copies of each application.
31. LAWS, REGULATIONS, POLICIES,
PROCEDURES
• The Federal Food, Drug, and Cosmetic Act is the basic food and
drug law of the U.S The law is intended to assure consumers that foods are
pure and wholesome, safe to eat, and produced under aseptic conditions;
that drugs and devices are safe and effective for their intended uses;
that cosmetics are safe and made from appropriate ingredients; and
that all labeling and packaging is truthful, informative, and not deceptive.
32. • Code Of Federal Regulations (CFR)
o The final regulations published in the Federal Register (daily published
record of proposed rules,final rules, meeting notices, etc.) are collected in
the CFR.
o The CFR is divided into 50 titles that represent broad areas subject to
Federal regulations.
o The FDA's portion of the CFR interprets the The Federal Food, Drug, and
Cosmetic Act and related statutes. Section 21 of the CFR contains most
regulations pertaining to food and drugs.
21CFRPart 312 Investigational New DrugApplication
21CFR Part314
INDAand NDAApplications for FDAApproval to Market aNew
Drug (New DrugApproval)
21CFR Part316 OrphanDrugs
21CFR Part58 Good LabPractice for Nonclinical Laboratory
[Animal] Studies
21CFR Part50 Protection of HumanSubjects
21CFR Part56 Institutional ReviewBoards
21CFR Part201 Drug Labeling
21CFR Part54 Financial Disclosure by Clinical Investigators
33. • CDER's Manual of Policies and Procedures (MaPPs)
(Center for Drug Evaluation and Research)
MaPPS are approved instructions for internal practices and procedures
followed by CDER staff to help standardize the investigational new
drug review process and other activities.
34. The Investigational New Drug (IND) Process:
Drug developers, or sponsors, must submit an Investigational New Drug (IND)
application to FDA before beginning clinical research. In the IND application,
developers must include:
• Animal study data and toxicity (side effects that cause great harm) data
• Manufacturing information
• Clinical protocols (study plans) for studies to be conducted
• Data from any prior human research
• Information about the investigator
35. FDA APPLICATION PROCESS
• IND contains:
• sufficient Chemistry, Manufacturing, and other Controls
• pre-clinical safety information describes the proposed human trial (Phase 1
• Multi-disciplinary Review Team
• 30-Day Deadline for Decision
• Team Decision
• Yes? “Okay to Proceed” No? Clinical HOLD
• Communication to sponsor: What work must sponsor do to get HOLD lifted?
36. FDA REVIEW OF THE INDA
Once the IND stamped as received ,it is sent to the review division
within CDER.
On arrival at the review division , it is critically evaluated byseveral
reviewers of
Chemist
Biopharmaceutics
Medical
Stastistics
Microbiology
Pharmacology /toxicology sections
40. FDA’SIND REVIEW PROCESS
• Safety Review:
• Following review of an initial IND submission, CDER has 30 calendar days in which to
decide or if a clinical hold is necessary (i.e., if patients would be at an unacceptable
risk or if CDER (Center for Drug Evaluation and Research) doesn't have the data to make such a
determination).
• Generally, drug review divisions do not contact the sponsor if no concerns arise with
drug safety and the proposed clinical trials.
• If the sponsor hears nothing from CDER, then on day 31 after submission of the
IND, the study may proceed as submitted.
41. CLINICAL HOLD DECISION
• A clinical hold is the mechanism that CDER uses when it does not believe, or cannot
confirm, that the study can be conducted without unreasonable risk to the
subjects/patients.
• If this occurs, the Center will contact the sponsor within the 30-day initial review
period to stop the clinical trial. CDER may either delay the start of an early-phase trial
on the basis of information submitted in the IND, or stop an ongoing study based on
a review of newly submitted clinical protocols, safety reports, protocol amendments,
or other information.
• When a clinical hold is issued, a sponsor must address the issue that is the basis of
the hold before the order is removed.
42. • CLINICAL HOLD
a clinical hold can be –
- “complete clinical hold” – a delay or Suspension of all clinical work requested
under IND submission
- “partial clinical hold”- a delay or suspension of only part of clinical work
e.g. part of protocol.
43. NOTIFYSPONSOR
• Once a clinical hold is placed on a commercial IND, the sponsor will be notified
immediately by telephone by the division director.
• the division is required to send a letter within five working days following the
telephone call.
• The letter should describe the reasons for the clinical hold, and must bear the
signature of the division director (or acting division director).
• The sponsor may then respond to CDER by sending an "IND CLINICAL HOLD
RESPONSE" letter to the division. To expedite processing, the letter must be clearly
identified as an "IND CLINICAL HOLD RESPONSE" letter.
44. • The division then reviews the sponsor's response and decides
within 30 days as to whether the hold should be lifted.
• If the division does not reply to the clinical hold response within
30 calendar days, the division director will telephone the sponsor
and discuss what is being done to facilitate completion of the
review.
• If it is decided that the hold will not be lifted, the hold decision is
automatically sent to the office director for review.
45. • The office director must decide
calendar days whether or not to
within 14
sustain the
division's decision to maintain the clinical hold.
• If the decision is made to lift the hold, the division telephones the
sponsor, informs them of the decision, and sends a letter
confirming that the hold has been lifted.
• The letter will be sent within 5 working days of the telephone call.
However, the trial may begin once the decision has been relayed
to the sponsor by telephone.
46. SPONSORNOTIFIEDOFDEFICIENCIES
• If other deficiencies are found in an IND that the review division determines are not
seriously enough to justify delaying clinical studies, the division may either
telephone or forward a DEFICIENCY LETTER to the sponsor.
• In either case, the division informs the sponsor that it may proceed with the planned
clinical trials, but that additional information is necessary to complete or correct the
IND file, or that there are issues that need to be addressed prior to a marketing
application (NDA) submission.
47. STUDYONGOING
• Once CDER's 30-day initial review period expires, clinical studies can
be initiated, unless a clinical hold has been placed.
48.
49. INDA ANNUALREPORTS
Sponsors should submit an annual report that provides the FDA with
a brief update on the progress of all investigations included in the
IND.
It should contain the following:
Individual study information.
Summary of the study.
Listing of any significant foreign marketing developments with the
drug
e.g. approval in another country.
When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to
establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
Goal :- to get the approval for new drug
to reduce the price of the drug
to reduce the time of development