Voisin Consulting Life Sciences glossary icon
Glossary

MedWatch

Loading..
Click a letter to view all its definitions

MedWatch is the US Food and Drug Administration’s reporting program for product complaints.

MedWatch

MedWatch an FDA-sponsored system for voluntarily reporting of serious adverse event, product quality problem, product use error, or therapeutic in equivalence/failure that is suspect to be associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. Suspected counterfeit medical products can also be reported through MedWatch.

MedWatch in the United States

The MedWatch is the FDA safety information and adverse event reporting program. This system facilitates the collection of reports of adverse reactions and quality problems, primarily with drugs and medical devices, but also for other FDA-regulated products (e.g., dietary supplements, cosmetics, medical foods, and infant formulas). It is intended to detect safety hazard signals for medical products. If a signal is detected, the FDA issues medical product safety alerts or order product withdrawals, recalls, or other labeling changes to protect the public health.

Other glossary definitions

S

Substantial Amendment (SA)

A substantial amendment (SA) is a change to the conduct of the clinical trial that…

View definition
C

Competent Authority

Is responsible for the authorization of medicines / medical devices and for ensuring that medicines…

View definition