FDA’s Glavin Moves From Counterterrorism Office To Head Regulatory Affairs
This article was originally published in The Pink Sheet Daily
Assistant Commissioner for Counterterrorism Margaret Glavin is named associate commissioner for regulatory affairs. She takes over for John Taylor, who is leaving FDA after 14 years. Glavin brings a background in food safety from her work at the Department of Agriculture.
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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.
Amended application includes 50 mg and 100 mg dosage forms, which are used in multiple myeloma.