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Home » FDA Will Accept New ANDAs Only With GDUFA Backlog Fee
FDA Will Accept New ANDAs Only With GDUFA Backlog Fee
December 30, 2011
The FDA hopes to take harsh measures to deal with its ANDA backlog, saying it would refuse to receive any new ANDAs or supplements from generic-drug makers that fail to pay a one-time ‘backlog’ fee under the pending Generic Drug User Fee Act (GDUFA) agreement.