MEDWATCH ADVERSE EVENT REPORTING PROGRAM | UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
Resource Name:MEDWATCH ADVERSE EVENT REPORTING PROGRAM | UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
address
10903 New Hampshire Avenue, Silver Spring, MD 20993
Eligibility
None.
Hours
M-F 8:00AM-4:30PM.
(888) 463-6332
Voice
Application process
Fill out the MedWatch Online Voluntary Reporting Form and submit here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
Fees
No fee for services.
Service area
United States
- Receives reports from the public for FDA-regulated products such as: Prescription and over-the-counter medicines Biologics such as blood components, blood/plasma derivatives and gene therapies Medical devices such as hearing aids breast pumps, and pacemakers Combination products such as pre-filled drug syringe, metered-dose inhalers and nasal spray Special nutritional products such as dietary supplements, medical foods and infant formulas Cosmetics such as moisturizers, makeup, shampoos, hair dyes and tattoos Food such as beverages and ingredients added to foods
Last assured
11/22/2024
What's Here
Providing organization
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
The United States Department of Health and Human Services Food and Drug Administration (FDA) is responsible for protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.