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Adverse Events, Direct From The Consumer

 
• By Martin Berman-Gorvine

FDA's proposed consumer version of the MedWatch form for reporting drug-related adverse events goes before an advisory panel.

FDA is asking its Risk Communications Advisory Committee to review a form specially designed to elicit information on drug- and device-related adverse events from consumers, using simplified instructions and a checklist-based format.

The new form is a variant of FDA's existing Form FDA 3500, which the agency makes available for voluntary reporting adverse event reporting by health care professionals and...

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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More from Regulatory Trackers

AMR-Targeting Drug Secures EMA PRIME Designation

 
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Global Pharma Guidance Tracker - March 2025

 
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