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
You may also be interested in...
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
Dispute Resolution Pilot Holds Promise Despite Slow Uptake – FDAer
FDA has received "positive feedback" from industry on its dispute resolution pilot for manufacturing site inspections, but will meet with various trade groups in September to discuss why firms are not participating
Drug Manufacturing: Industry Urges FDA “For Cause” Preapproval Inspections
FDA should consider moving to "for cause" preapproval inspections (PAIs) as part of its quality systems initiative, drug manufacturers told FDA at the Product Quality Research Institute/FDA conference in Washington, D.C. April 24