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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.

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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