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FDA Supplement AE Monitoring System Has "Six Problem Areas" - Burton

This article was originally published in The Tan Sheet

Executive Summary

"Six problem areas" exist in the FDA Center for Food Safety & Applied Nutrition adverse event monitoring system for dietary supplements that need to be resolved, House Government Reform Committee Chairman Dan Burton (R-Ind.) declared at a May 27 hearing.

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Adverse event reports should be required to contain certain information before being filed in the CFSAN Adverse Events Reporting System (CAERS), AHPA says in an Oct. 21 letter to the agency

Mandatory AE Information Requirements Needed For CAERS Filings – AHPA

Adverse event reports should be required to contain certain information before being filed in the CFSAN Adverse Events Reporting System (CAERS), AHPA says in an Oct. 21 letter to the agency

Mandatory AE Information Requirements Needed For CAERS Filings – AHPA

Adverse event reports should be required to contain certain information before being filed in the CFSAN Adverse Events Reporting System (CAERS), AHPA says in an Oct. 21 letter to the agency

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