Durbin Requests GAO Inquiry On Supplement Adverse Event Reports
This article was originally published in The Tan Sheet
Executive Summary
Sen. Durbin says it is unclear how FDA’s adverse event reporting system works to protect consumer safety and asks GAO to investigate the agency’s collection and analysis of dietary supplement AERs.
You may also be interested in...
Supplement AER Under-Reporting Marks Tip Of Compliance Iceberg – FDA
FDA’s dietary supplement program chief raised eyebrows at a botanical products conference citing low estimates on rates of compliance with the good manufacturing practices final rule and the new dietary ingredient notification requirements, as well as adverse event reporting.
Supplement AER Under-Reporting Marks Tip Of Compliance Iceberg – FDA
FDA’s dietary supplement program chief raised eyebrows at a botanical products conference citing low estimates on rates of compliance with the good manufacturing practices final rule and the new dietary ingredient notification requirements, as well as adverse event reporting.
Hydroxycut Recall Eyed As Trigger For Closer Look At Supplement AERs
The dietary supplement industry looks to FDA's Hydroxycut investigation for a sign on whether the agency will analyze adverse event reports more closely following a high-profile product recall