The FDA Safety Information and Adverse Event Reporting Program
“Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products.”
Consumers and the Food and Drug Administration (FDA)
Consumers play an important public health role by reporting to the FDA any adverse events (unexpected side effects) after using a medical product, or other problems with any products that the agency regulates. Timely reporting allows the agency to take prompt action. There are a number of ways you can report problems to the agency, depending on the type of problem and product.
What is MedWatch?
MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, such as drugs and medical devices.
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Report Adverse Events Directly to the FDA MedWatch Program