RAPS

New Medwatch Form Geared Toward Simple Adverse Event Reporting for Consumers

The US Food and Drug Administration (FDA) is touting the 20 th anniversary of one of its most essential safety reporting tools, MedWatch, which it uses to collect adverse event reports about ...
RAPS

FDA Proposes Changes to its Adverse Event Reporting Forms

The US Food and Drug Administration (FDA) is proposing several changes to its adverse event reporting forms, known within the industry as Forms 3500, 3500A and 3500B. FDA has three adverse event ...
JD Supra

Prepare for MoCRA’s New Adverse ‎Event Requirements Now

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is bringing sweeping changes to the cosmetics industry. One such change requires a “responsible person” to maintain and submit certain ...
The Scientist

The FDA's New Adverse Event Dashboard: More Data Doesn't Mean a Better Understanding

On March 11, the FDA launched the Adverse Event Monitoring System (AEMS), consolidating several fragmented reporting databases into a single real-time public dashboard with artificial intelligence ...
Healio

FDA begins daily reporting of adverse event data

Please provide your email address to receive an email when new articles are posted on . The FDA Adverse Event Reporting System will now host daily publications, instead of quarterly. The agency’s goal ...