New FDA Fees for Drug Master Files published

The US FDA has published the new fees for 2014. In a Federal Register Statement dated August 2, 2013 the following information has been published: Under the Generic Drug User Fee Act (GDUFA), the Drug Master File (DMF) fee is owed by each person that owns a type II active pharmaceutical ingredient DMF that is referenced, on or after October 1, 2012, in a generic drug submission by an initial letter of authorization. This is a one-time fee for each individual DMF.

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