FDA Regulations

The Food and Drug Administration (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.”

Research studies involving human subjects must comply with federal regulations. The Code of Federal Regulations (CFR) Title 21 CFR is specific to rules and regulations of the FDA. Regulations pertaining to human subjects research include:

FDA Resources

Searchable Database for Federal Regulations (Title 21)
FDA Guidance Documents
FDA Information Sheets
FDA on Financial Disclosures
Exception from Informed Consent Requirements for Emergency Research
Information for Health Professionals

Investigational New Drug (IND)

Center for Drug Evaluation and Research (CDER)
Sponsor-Investigators Submitting Investigational New Drug Applications

Investigational Device Exception (IDE)

Center for Devices and Radiological Health (CDRH)
Clinical Trials and Investigational Device Exemption

Biologics

Center for Biologics Evaluation and Research (CBER)
Submitting an Investigational New Drug Application for a Biological Product