FDA Regulations

U.S. Food and Drug Administration (FDA) Regulations and Guidance

Click on the following link for the U.S. Food and Drug Administration (FDA) webpage

Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both.

FDA Pages

Code of Federal Regulations (CFR) Title 21

21 CFR 11: Electronic Records; Electronic Signatures
21 CFR 50: Protection of Human Subjects, Informed Consent
21 CFR 54: Financial Disclosure
21 CFR 56: Institutional Review Boards
21 CFR 312: Investigational New Drugs
21 CFR 314: FDA Approval to Market a New Drug (NDA)
21 CFR 600: Biologics, general
21 CFR 601: Biologics, licensing
21 CFR 812: Investigational Devices
21 CFR 814: Medical Devices, Pre-Market-Approval (PMA)
21 CFR 860: Medical Devices, Classification Procedures

FDA Guidance and Information Sheets

FDA Regulations

FDA Regulations

U.S. Food and Drug Administration (FDA) Regulations and Guidance

Research Compliance