MedWatch Adverse Event Reporting Program
(Program)
- 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.
Eligibility: None.
Application Process: Fill out the MedWatch Online Voluntary Reporting Form and submit here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
Required Documentation: Reporting form. Call or visit website for more information.
Fees: No fee for services.
United States
United States Department of Health and Human Services Food and Drug Administration
(Agency)
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.
10903 New Hampshire Avenue
Silver Spring MD 20993
Website: www.fda.gov
Hours: M-F 8:00AM-4:30PM
Contact
Website: www.fda.gov/safety/med . . . ng-program
10903 New Hampshire Avenue
Silver Spring MD 20993
This program is offered at this site:
United States Department of Health and Human Services/ Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring MD 20993
