21 CFR 50 Protection of Human Subjects
21 CFR 56 Institutional Review Boards
21 CFR 312 Investigational New Drug Applications
21 CFR 812 Investigational Device Exemptions
45 CFR 56 Protection of Human Subjects
45 CFR 164 Security and Privacy
FDA Clinical Trials Guidance
FDA Guidance for IRBs – Investigators and Sponsors
FDA Medical Devices Guidance
OHRP Guidance Documents
OHRP Human Subject Regulation Decision Charts
