RAPS

Switch in Adverse Event Reporting Forms Increased Quality and Quantity of Reports, FDA Study Finds

Since 1969, health professionals and consumers have been able to voluntarily report pharmaceutical adverse events to FDA’s Adverse Event Reporting System (FAERS), and with a shift to plain language in ...
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 ...
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 ...
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 ...