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Home » FDA Publishes GDUFA Goals Letter, Estimates Fee Levels in Package
FDA Publishes GDUFA Goals Letter, Estimates Fee Levels in Package
January 4, 2012
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 do not pay a one-time ‘backlog’ fee under the pending Generic Drug User Fee Act (GDUFA) agreement.