CDER’s Drug Quality Office Separates Oversight Of ‘New’ And ‘Lifecycle’ Products
This article was originally published in The Pink Sheet Daily
January launch of long-awaited Office of Pharmaceutical Quality is part of broader Center reorganization that also includes new Office of Study Integrity and Surveillance.
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More than just a bureaucratic shell game, the promotion of the Office of Generic Drugs to “super office” status signals CDER Director Janet Woodcock’s tightened focus on generic drugs.
Pair of letters that target research focus and therapeutic review speed is a potential preview of the kind of oversight that the agency may be subject to if the GOP retakes control of the House this fall.