MedWatch
MedWatch
MedWatch (/ˈmɛdwɒtʃ/) is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence, and product use errors with human medical products, including drugs, biologics, medical and radiation-emitting devices, and dietary supplements.
Etymology
The term "MedWatch" is a portmanteau of "Medical" and "Watch", indicating the program's role in monitoring the safety of medical products.
History
MedWatch was established in 1993 by the Food and Drug Administration (FDA) to serve as a system for collecting data about adverse events in healthcare. The program's goal is to improve patient safety by providing a platform for healthcare professionals and consumers to report and learn about adverse events associated with medical products.
Function
MedWatch serves as a post-marketing surveillance system, collecting information about adverse events that occur after a product has been approved by the FDA. Healthcare professionals and consumers can submit voluntary reports of serious adverse events, product quality problems, therapeutic inequivalence, and product use errors to MedWatch. The FDA uses these reports to identify safety concerns associated with medical products and take appropriate regulatory action.
Related Terms
- Adverse Event: An unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and suspected to be related to the drug.
- Food and Drug Administration (FDA): The federal agency responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed, and veterinary products.
- Post-marketing Surveillance: The practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market.
External links
- Medical encyclopedia article on MedWatch
- Wikipedia's article - MedWatch
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