21 CFR Part 11 |
Electronic Records; Electronic Signatures |
21 CFR Part 50 |
Human Subject Protection (Informed Consent) |
21 CFR Part 50, subpart D |
Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products |
21 CFR Part 54 |
Financial Disclosure by Clinical Investigators |
21 CFR Part 56 |
Institutional Review Boards |
21 CFR Part 312 |
Investigational New Drug Application |
Forms 1571 and 1572 |
Investigational New Drug Application and Statement of Investigator |
21 CFR Part 314 |
Applications for FDA Approval to Market a New Drug |
21 CFR Part 601 |
Applications for FDA Approval of a Biologic License |
21 CFR Part 812 |
Investigational Device Exemptions |
21 CFR Part 814 |
Premarket Approval of Medical Devices |