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After Issuing 40 Drug GMP Warning Letters in FY 2012, FDA Aims to Improve Drug Quality This Year

This article was originally published in The Gold Sheet

Executive Summary

FDA Commissioner Margaret Hamburg said that improving drug product quality will be one of the agency’s highest priorities this year and advised industry to do the same as the agency spearheads a number of new initiatives in this area. Yet is FDA taking a similarly aggressive approach to enforcement, given that the number of drug GMP warning letter declined 23%?


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