Basics on the FDA: The FDA is a U.S. government agency with authority to regulate food, drugs, medical devices, cosmetics, livestock feeds, pet foods, and tobacco products. The FDA web site is at www.fda.gov, and phone numbers are available through the Contact page.
FDA documents not available on the FDA website can often be purchased from FOI Services. These include:
- Petitions (Citizen Petitions, Food Additive Petitions, Color Additive Petitions);
- Drug Approval Letters, Package Inserts and Labeling, FDA Final Reviews and the Summary Basis of Approval (SBOA);
- Medical device documents including 510(k) Notifications, Pre-Market Approval Notifications (PMA Notifications), Medical Device / Adverse Reaction Notifications;
- Inspection Reports (EIRs, 483s, warning letters and related correspondence),
- Guidelines and Guidance Manuals, Advisory Committee Meeting minutes and transcripts, etc.