Regulations and Guidance Documents Relating to Clinical Research

Information regarding requesting and preparing for formal meetings with the FDA (PDF - 84 KB)

The most common initial meeting with the FDA is a pre-IND meeting (21 CFR 312.82).

Additional information regarding the scheduling and conduct of formal meetings

Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting (dated September 1, 2015)

Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting

Information on Submitting an Investigational New Drug Application (IND) for a Biological Product: This link includes the following applicable regulations and more.

The Electronic Code of Federal Regulations
The IND regulations contained in 21 CFR Part 312
The informed consent regulations at 21 CFR Part 50
The Institutional Review Board (IRB) regulations at 21 CFR Part 56

Guidance for Sponsors, Investigators and Institutional Review Boards: Questions and Answers on Informed Consent

, 21 CFR 50 25(C) (PDF - 56 KB)

Guidance for Clinical Investigators, Sponsors and IRBs – Adverse Event Reporting to IRBs, Improving Human Subject Protection

Guidance_for_Clinical_Investigators_Sponsors_and_IRBs.pdf (PDF - 57 KB)

Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB (PDF - 158 KB)

Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators (PDF - 165 KB)

Human Subject Protection – Information for Institutional Review Boards, Clinical Investigators, and Sponsors

HHS Policy for Protection of Human Subjects

Human Participant Protections Education for Research Teams

This free, web-based course presents information about the rights and welfare of human participants in research. The two-hour tutorial is designed for those involved in conducting research involving human participants. It satisfies the NIH human subjects training requirement for obtaining Federal Funds.

List of guidance documents related to submission of INDs

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

FDA regulations on the exportation of investigational new drugs, including biological products

[70 Federal Register at 70,720 (Nov. 2005)] (PDF - 186 KB)

Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF - 774 KB)

Final Rule: Investigational New Drug Safety Reporting Requirement for Human Drug and Biological Products and Safety Reporting Requirement for Bioavailability and Bioequivalence Studies in Human

Regulations and Guidelines Relating to Gene Therapy Research

General information regarding the FDA regulation of Cellular and Gene Therapies

Interactions with Office of Therapeutic Products (OTP)

FDA Expectations for INDs for Cellular and Gene Therapy

McFarland.pdf (PDF - 87 KB)

Gene Therapy Clinical Trials Observing Subjects for Delayed Adverse Events

NIH Office of Science Policy

Regulations and Guidance Documents Relating to Animal Research