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

Reporting Adverse Events: FDA Seeks Comments on Revisions to Submission Forms

FDA on Thursday sought comments on modifications and revisions the agency is planning to make to the forms used by health professionals, drugmakers and hospitals to report adverse events. The proposed ...
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 ...
National Academies of Sciences%2c Engineering%2c and Medicine

Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary

Active surveillance systems screen claims data and notify healthcare providers who then determine if follow-up or adverse event reporting is required. These systems can scan for known adverse events ...