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FDA Needs To Track Actions Built On Supplement AERs – GAO Report

 
• By Lisa Gillespie

A GAO report says FDA “may be able to expand” its use of supplement adverse event reports if it can track its use of the data to support actions it takes to protect consumers. The report makes five key recommendations for the agency to improve its approach to AERs.

FDA needs to create a system to track its use of dietary supplement adverse event reports to prompt consumer protection actions to provide clear direction for its future use of the data, the Government Accountability Office finds.

GAO arrived at five recommendations in its March 18 report on FDA’s use of AERs in overseeing dietary supplements (see table below).

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More from North America

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

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US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.