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Getting Organized for GDUFA: FDA Elevates Generic Review Activities Under New Director Geba

 
• By Cole Werble

In the two months since the enactment of the Generic Drug User Fee Act, FDA has announced a major recruitment from the brand sector to head its generic drug activities (Gregory Geba), approved one controversial transdermal generic (Watson’s lidocaine topical patch), and elevated the generic review activities to “Super Office” status.

The Food & Drug Administration’s generic drug review activities are getting organizational status and a direct line to the top of FDA’s drug activities to reflect the new funding enacted by the FDA Safety & Innovation Act.

In a change announced September 7, Center for Drug Evaluation & Research Director Janet Woodcock made the generic review group...

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• By Mandy Jackson and Joseph Haas

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