Glossary of Clinical Terms

“MedWatch” is the US FDA’s (Food and Drug Administration) safety information and adverse event reporting program for drugs, medical devices, biologics, and other FDA-regulated products. The program is designed to allow healthcare professionals and patients to report serious problems or adverse events associated with the consumption and/ or use of medicinal products to the FDA so that the agency can take appropriate regulatory action if necessary.

Healthcare professionals and patients can use the MedWatch program to report serious problems such as:
1️⃣ Unexpected side effects or adverse events related to a drug, medical device,
or biologic.
2️⃣ Product quality issues. (e.g., defective or contaminated products)
3️⃣ Medication errors or problems with product labeling or instructions.
4️⃣ Suspected counterfeit or unapproved products.

The MedWatch program is an important tool for promoting the safe use of drugs, medical devices, and other FDA-regulated products, and for helping the FDA identify and address potential safety issues. Reporting adverse events and other problems to the FDA through MedWatch can help improve the safety and effectiveness of medical products, and ultimately benefit patients and public health.

“MedWatch” at times is also addressed as the watchdog of the US FDA for the benefit of the American people.