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

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 ...
Becker's ASC

Patient Safety Tool: Adverse Event Reporting Form for Office-Based Surgery

The New York State Department of Health offers a free, downloadable adverse event reporting form for office-based surgery. The four-page form includes sections detailing accreditation, the nature of ...
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 ...