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GSK Paxil, Avandamet Seizure Will Have “Ripple Effect” On GMPs, FDAer Says

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA hopes the seizure will serve as a warning to other manufacturers that do not heed guidelines for good manufacturing practices. The decision to bypass other regulatory options was made in consultation with Acting Commissioner Crawford. FDA is currently negotiating a consent decree with GSK.

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