Science & Research
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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)
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