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  1. MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Medical Product Safety Educational Resources

MedWatch: Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.


This short graphic video gives medical professionals an overview of the MedWatch program with information about how to sign up for it and how to use it. Run time 1 min 27 sec

The FDA regulates a wide range of products, including drugs for people and animals, biologics, medical devices, dietary supplements, infant formulas, and cosmetics. Consumers can report unexpected side effects, adverse events, or other problems they may experience with a regulated product through FDA's MedWatch program. Run time 2 min 20 sec

La FDA regula una amplia variedad de productos, que incluyen medicamentos para personas y animales, productos biológicos, dispositivos médicos, suplementos dietéticos, fórmulas infantiles y productos cosméticos. Los consumidores pueden reportar efectos secundarios inesperados, eventos adversos u otros problemas con productos regulados a través del programa MedWatch de la FDA.

FDA needs to know when a serious problem with a medical product is suspected or identified in clinical use. FDA Drug Info Rounds pharmacists discuss how FDA’s MedWatch program makes it easy to get important safety information directly from you to us. Run time 3 min 14 sec

FDA's MedWatch Program is a valuable resource for nurses in any practice setting, providing important information on all medical products as well as for reporting problems with them. Run time 2 min

From styling our hair to showering before bed, Americans love cosmetics. Most are safe, but some cause problems, and that's when the Food and Drug Administration gets involved. Run time 1 min 34 sec

Additional Resources

  • MedWatch Learn

    MedWatchLearn teaches health professionals, and consumers how to complete the forms necessary to report problems to FDA. Here, you have the opportunity to practice filling out FDA Form 3500 (for health professionals) or FDA Form 3500B (for consumers).

  • FDA Case Studies

    Each case study promotes active learning through exercises, instructor-led discussions, and quizzes. Designed as a fictional case study based on a real-world scenario, the curriculum follows a format similar to Harvard Business Review Case Studies and builds on previous case studies.

  • BeSafeRx: Know Your Online Pharmacy

    A national campaign to raise awareness of the dangers of buying prescription medicines from fake online pharmacies.

  • Introducing MedWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems, JAMA, June 2, 1993, Vol 269, No 21. David Kessler, MD.

    Original article announcing the implementation and rationale for the MedWatch program.

MedWatch safety alerts delivered to you

Clinically important and timely information about the drugs and devices you use, prescribe, or dispense every day, delivered to your email from the FDA.

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