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Regulatory Resources

We know that there are many regulatory resources and guidance out there when developing your protocol and conducting your research. Here, we have organized some of the most often-used regulatory sites into one area for your reference.

We know that there are many regulatory resources and guidance out there when developing your protocol and conducting your research. Here, we have organized some of the most often-used regulatory sites into one area for your reference.

Office of Human Research Protections (OHRP)

Food and Drug Administration (FDA)

Adverse Event Reporting
- FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection
- FDA webpage: “What is a Serious Adverse Event?”
Drug label changes per FDA-How to Receive Email Updates About FDA Drug Label Changes
FDA Guidance: Expanded Access to Drugs for Treatment Use (updated 2017)
How to submit an Expanded Access Request (FDA)
Individual Expanded Access Applications: Form 3926 (2017)
21 CFR 50-Informed Consent and Children
21 CFR 56- Institutional Review Boards
21 CFR 312-INDs
21 CFR 812- IDEs
Emergency IND FDA Information Sheet

NIH Resource Links