Home » FDA Wants to Place ANDAs, Supplements on Hold for Generic Makers That Don’t Pay Backlog Fee
FDA Wants to Place ANDAs, Supplements on Hold for Generic Makers That Don’t Pay Backlog Fee
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.
Drug Industry Daily
Drug Industry Daily
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