Research Resources

UPitt Links

UPMC Links

Food and Drug Administration (FDA) Regulations

Code of Federal Regulations Title 21

  • Title 21 CFR 11: Electronic records; electronic signature 
  • Title 21 CFR 54: Financial disclosure by clinical investigators
  • Title 21 CFR 50: Protection of human subjects—informed consent
  • Title 21 CFR 56: Institutional review boards
  • Title 21 CFR 312: Investigational new drugs
  • Title 21 CFR 314: FDA approval to market a new drug
  • Title 21 CFR 600: Biological products
  • Title 21 CFR 601: Licensing
  • Title 21 CFR 812: Investigational devices
  • Title 21 CFR 814: Pre-market approvals (PMAs) of medical devices

Ethics Documents

Guidance Documents

Professional Organizations