Approvals of FDA-Regulated Products

Approval information by product type

Drugs

Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes)

• Drug Approval Reports by Month
• Drugs@FDA
• Postmarket Drug Safety Information for Patients and Providers
• Prescription Drug User Fee Amendments

Biological Products

Vaccines, tissue, blood, and other products derived from living sources

• Biologics Products & Establishments

Medical Devices

Instruments or products used for treating or diagnosing disease (such as thermometers, artificial hearts, and home pregnancy test kits)

• Device Approvals and Clearances
• Recently-Approved Devices

Animal Drugs

• Animal Drugs @ FDA
• Animal Drug User Fee Act (ADUFA)
• Animal Generic Drug User Fee Act (AGDUFA)

Food Additives

• Food and Color Additives: Final Rules by Year
• Food Additive Petitions for Animal Food