Drug GMP Warning Letter Downtrend Accelerates In FY 2003
This article was originally published in The Tan Sheet
Executive Summary
The number of good manufacturing practice (GMP) warning letters issued to pharmaceutical firms by FDA fell by half in the agency's 2003 fiscal year
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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