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FDA GMP Initiative Shifts Warning Letter Review Back To Centers

This article was originally published in The Tan Sheet

Executive Summary

The Center for Drug Evaluation & Research will begin reviewing GMP warning letters March 1 as part of FDA's initiative to create a risk-based approach to pharmaceutical manufacturing

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A growing preference for voluntary compliance from drug firms is one contributor to the "steady decrease in the number of CDER warning letters," according to FDAer Robert Maffei

Fewer Warning Letters: Does Change Point To FDA Advancement Or Decline?

A growing preference for voluntary compliance from drug firms is one contributor to the "steady decrease in the number of CDER warning letters," according to FDAer Robert Maffei

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