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FDAnews Drug Daily Bulletin
Sept. 11, 2012 | Vol. 9 No. 178
CDER Proposes Supersizing Office of Generic Drugs, Mulls New Pharma Quality Office
CDER is looking to elevate the Office of Generic Drugs (OGD) into a “super” office, a move necessitated by the recent passage of the Generic Drug User Fee Amendments (GDUFA) and a heightened public focus on generic medicines, Center Director Janet Woodcock said Friday. Under this plan, the OGD and its newly appointed director, Greg Geba, would report directly to Woodcock. Acting Director of the Office of Executive Programs Mary Beth Clarke would continue to be the CDER lead on GDUFA implementation, Woodcock added in a letter to CDER staff.
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