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Home » FDA’s GDUFA Implementation Leads to ANDA Rejection Letter Avalanche
FDA’s GDUFA Implementation Leads to ANDA Rejection Letter Avalanche
November 11, 2013
In the FDA’s first year of implementing the Generic Drug User Fee Act, the agency issued some 1,250 complete response (CR) letters for ANDAs, a whopping increase from the fewer than 50 issued in fiscal 2012.