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U.S. Food and Drug Administration (FDA) – MedWatch Program fax number

(800) 332-0178

MedWatch

Used for: Adverse event and safety reporting for FDA-regulated products via the MedWatch program.

Fax destination details

Department
MedWatch
Purpose
Adverse event and safety reporting for FDA-regulated products via the MedWatch program.
Form
Form FDA 3500 (MedWatch) — MedWatch Form FDA 3500
Address
MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Voice phone
1-800-332-1088

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Download the MedWatch form (FDA Form 3500) or request a form by phone; complete and submit by fax to 1-800-FDA-0178 or submit online via the MedWatch portal.

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