Oct 22, 2025 · Heath professionals, consumers and patients can submit voluntary reports using MedWatch Online or by downloading, completing and then submitting FDA Form 3500 (health …

attest that Clinical notes and all pertinent documentation (i.e., labs) associated with the current ADR or therapeutic failures are attached. The benefits of the treatment outweigh the risks and verify that the …

How to submit report: To report by phone, call toll-free: 1-800-FDA (332)- 1088 To fax report: 1-800-FDA (332)-0178 To report online: www.fda.gov/medwatch/report.htm

Sep 26, 2025 · Use MedWatch to report a serious adverse event, product quality problem, product use error, therapeutic inequivalence/failure, or suspected counterfeit.

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics...

You have accessed the MedWatch precertification form. Please enter as much information as possible in the spaces provided, even if you do not have all the information requested on this form. The data …

When do I use this form? • You had a sudden or unsafe effect (including new or worsening symptoms) after taking a drug or using a device or product. • Due to a confusing label or instructions, you used a …

Oct 22, 2025 · MedWatch alerts provide timely, actionable safety information on human drugs, medical devices, biologics, dietary supplements, and cosmetics.

Downloadable FDA document providing information about safety reporting, adverse events, product issues, and medication errors. Accessible for voluntary reporting purposes.

For use by user-facilities, Form Approved: OMB No. 0910-0291, Expires: 9/30/2018 See PRA statement on reverse.