MedWatch: Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
The FDA regulates a wide range of products, including drugs for people and animals, biologics, medical devices, 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.
La FDA regula una amplia variedad de productos, que incluyen medicamentos para personas y animales, productos biológicos, dispositivos médicos, 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.
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).
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.
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.