MedWatch
What is it?
MedWatch is the FDA's safety information and adverse event reporting program, the US counterpart to what EudraVigilance is for the EU. It's both a reporting portal, where healthcare professionals, patients, and industry can submit adverse event and product problem reports for drugs, biologics, and medical devices, and an outbound safety alert system, publishing recalls and label changes as they happen.
For an MAH marketing in the US, MedWatch reporting sits alongside whatever regional reporting obligations already apply elsewhere, covering the same underlying case but routed through a different national system.
Common Misconceptions
"Isn't MedWatch just for the really serious stuff, recalls and major safety scares?"
MedWatch handles the full range, from mandatory serious-event reporting by industry down to voluntary reports from a patient who noticed something minor. The safety alerts are the visible tip of a much broader, continuous reporting system underneath.
