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medwatch
Guideline or reference source
FDADST An FDA Guide to Drug Safety Terms
Definition
MedWatch6 is FDA's safety information and adverse event reporting program. It provides important and timely medical product information to health care professionals, including information on prescription and over-the-counter drugs, biologics, medical devices, and special nutritional products. Health care professionals and consumers can also report serious problems they suspect are related to certain FDA-regulated products.  

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