The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. The FDA regulations that involve human subjects are 21 CFR 312, 21 CFR 50, 21 CFR 56, 21 CFR 54, 21 CFR 600, and 21 CFR 812.
Food and Drug Administration (FDA) Homepage
Resources, Information Sheets, Databases
Food and Drug Administration Regulations - Title 21 Searchable Database
Comprehensive list of Food & Drug Administration Guidance Documents
Information Sheets
Information for Health Professionals
Financial Disclosure by Clinical Investigators - 21 CFR 54
Institutional Review Board (IRB) / Informed Consent
Protection of Human Subjects (FDA Informed Consent) - 21 CFR 50
Institutional Review Boards - 21 CFR 56
Exception from Informed Consent Requirements for Emergency Research. (Draft)
Investigational New Drug (IND)
Center for Drug Evaluation and Research (CDER)
Investigational New Drug (IND) Application - 21 CFR 312
Information for Sponsor-Investigators Submitting Investigational New Drug Applications
Investigational Device Exception (IDE)
Center for Devices and Radiological Health (CDRH)
Investigational Device Exemptions (IDE) - 21 CFR 812
Clinical Trials and Investigational Device Exemption (application information)
Biologics
Center for Biologics Evaluation and Research (CDRH)
Information on Submitting an Investigational New Drug Application for a Biological Product
Biological Products: General - 21 CFR 600