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.
Źródło wiadomośći: http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18625.pdf