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CFSAN AER system

This article was originally published in The Rose Sheet

Executive Summary

Center for Food Safety & Applied Nutrition expects to have new adverse events reporting system for cosmetics, food and color additives and dietary supplements in place by May 2003, FDA reports. CFSAN Adverse Event Reporting System (CAER), which is undergoing pilot testing, will replace existing three AER systems. Older versions will remain in place until new system is implemented, agency says. Beginning on or after Sept. 16, CFSAN will send letters to companies notifying them when an AER involving one of their products has been received. Under Senate Agriculture Appropriations bill, CFSAN's AER system would receive $7.6 mil. in FY 2003 funding (1"The Rose Sheet" Aug. 5, 2002, In Brief)...

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Center for Food Safety and Applied Nutrition Adverse Events Reporting System would receive $7.6 mil. in FY 2003 funding under Senate Agriculture Appropriations bill, which unanimously passed out of committee July 25. CAERS funding represents $2 mil. more than budget request. Measure also provides $2 mil. for botanical research carried out by FDA, U-Miss. center. Bill calls for $149.3 mil. in funding for CFSAN and total FDA funding of $1.39 bil., which is $23.4 mil. more than budget request. Full Senate vote has yet to be scheduled...

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