FDA Regulations Relating to Good Clinical Practice and Clinical Trials

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Preambles to GCP Regulations - information about the development of final rules related to FDA's regulations on good clinical practice and clinical trials.

• Electronic Records; Electronic Signatures (21 CFR Part 11)
• Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
• Financial Disclosure by Clinical Investigators (21 CFR Part 54)
• Institutional Review Boards (21 CFR Part 56)
• Investigational New Drug Application (21 CFR Part 312)
• Foreign Clinical Trials not conducted under an IND (21 CFR Part 312.120)
• Form 1571 (Investigational New Drug Application)
• Form 1572 (Statement of Investigator)
• Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
• Bioavailability and Bioequivalence Requirements (21 CFR Part 320)
• Applications for FDA Approval of a Biologic License (21 CFR Part 601)
• Investigational Device Exemptions (21 CFR Part 812)
• Premarket Approval of Medical Devices (21 CFR Part 814)