MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Find clinically important safety information and report serious problems with human medical products.

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness.

Medical Product Safety Educational Resources

Brief videos and safety information resources for health professionals

Expanded Access: Information for Physicians

Information and resources on expanded access, sometimes called “compassionate use”.

Advisory Committees

Drugs@FDA