Investigational new drug (IND) Definition categories application format content

 

INVESTIGATIONAL NEW DRUG

Definition

Categories

IND application

IND Format

Content

An Investigational New Drug (IND) application is a request submitted to the United States Food and Drug Administration (FDA) to initiate clinical testing of a new drug in humans.

The purpose of an IND is to provide the FDA with sufficient information about the drug and its safety and efficacy to support the proposed clinical trials.

There are three categories of IND applications:

Commercial IND: This is for a drug that is intended to be marketed commercially.

Research IND: This is for a drug that is intended solely for use in research.

Emergency Use IND: This is for a drug that is intended to treat patients with a serious or immediately life-threatening disease or condition.

The content of an IND application must include the following:

General information, such as the name and address of the sponsor, the name of the drug, and a summary of the proposed clinical trials.

Preclinical data, such as animal pharmacology and toxicology studies.

Manufacturing information, such as the composition and stability of the drug product, and the methods used to manufacture and test the drug.

Clinical protocols, including the design of the proposed clinical trials, the number of subjects to be enrolled, and the criteria for subject selection.

Investigator's brochure, which is a document that provides essential information about the drug to the investigators who will be conducting the clinical trials.

The format of an IND application is specified by the FDA and includes a cover letter, table of contents, and numbered sections.

The application must be accompanied by a fee, which varies depending on the type of IND and the phase of clinical development.

The FDA reviews the IND application to ensure that the proposed clinical trials are safe and ethical and that the drug has a reasonable likelihood of being effective.

Format:

1.  Cover sheet-contains sponsor and investigator information, identification of the clinical investigation phase(s), and any commitments

2.   Table of contents

3.   Introductory statement and general investigational plan-provides information about the dosage form and route of administration, a brief history of the drug, and a description of the overall plan for clinical investigations

List of IND Content

1.Cover sheet (e.g., 21 CFR 313.23(a)(2))

2. Introductory statement and general investigational plan (e.g., 21 CFR 313.23(a)(3))

3. Investigator's brochure (e.g., 21 CFR 313.23(a)(5))

4. Protocols (e.g., 21 CFR 313.23(a)(6))

5. Chemistry, manufacturing, and control information (e.g., 21 CFR 313.23(a)(7)(iv))

6. Pharmacology and toxicology information (e.g., 21 CFR 313.23(a)(8)) 7. Previous human experience with investigational drug (e.g., 21 CFR 313.23(a)(9))

 

8. Additional information (e.g., 21 CFR 313.23(a) (10))

9.Relevant information as requested by the FDA (e.g., 21 CFR 313.23(a)(11))

4. Investigator's brochure- It contains a brief description of the drug substance and formulation which includes information on the pharmaceutical and toxicological effects of drugs in animals and in humans if known; safety and effectiveness in humans from prior clinical studies; and anticipated possible risks and side effects

5 Protocols- It contains detailed descriptions for each planned study, including objectives of the study, criteria for patient selection, design of study, methods used, and results.

6. chemistry, manufacturing and control information- it includes basic information on drug substance, drug product, any placebo used in a clinical trial, supportive stability data, labeling to be provided to each investigator and environmental analysis requirements

7. Pharmacology and toxicology information-It provides information from pharmacological and toxicological studies used to conclude that the drug is safe for clinical trials.

8. Previous human experience with investigational drug. It contains description of prior experience with the investigation or marketing of the investigational drug either in the United States or in other countries

9. Additional information- It contains information regarding drug dependence and drug abuse potential and description of studies performed for certain special drugs, such as radioactive dosimetry calculations or pediatric safety and effectiveness

10. Relevant information- It contains any other relevant information, as requested by the FDA The IND should demonstrate that the sponsor can adequately produce and supply consistent batches of the drug product, that the proposed product is safe for initial testing, and that the clinical investigators are qualified to perform their assigned trial duties.