MedWatch "Contact MedWatch" page

Contacting MedWatch

Mailing address:
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Office Of The Commissioner
Office of Scientific and Medical Programs
5600 Fishers Lane, Room 12B05
Rockville, MD 20857
For answers to questions about specific products:

FDA Index
Drug Information Pathfinder

Call 1-888-INFO-FDA (1-888-463-6332) to speak to an FDA representative, or:

Product Type E-mail Inquiries Telephone Inquiries

Drugs Drug Information Questions and Comments
Division of Drug Information,
301-796-3400 or
1-888-INFO-FDA
(1-888 463-6332)

Special Nutritional Products
(dietary supplements, infant formulas, and medical foods) and Cosmetics Food, Nutrition, and Cosmetics Questions & Answers 1-888-723-3366

Medical Devices Center for Devices and Radiological Health Comments and Feedback Page
1-800-638-2041

Vaccines, blood products, other biologics Center for Biologics Evaluation and Research Contact Page 1-800-835-4709

Questions about how to complete the MedWatch 3500 voluntary reporting form Questions and Comments 301-796-3400 or
1-888-INFO-FDA
(1-888 463-6332)

To submit a voluntary report about an adverse event, medication error, or medical product quality problem:

Report Online
Download the MedWatch 3500 form
Call 1-800-FDA-1088 (1-800-332-1088)

Questions about mandatory reporting
Where to send mandatory reporting forms