Business · 25/10/2012

FDA Announces Generic Drug User Fee Rates for Fiscal Year 2013

The Food and Drug Administration (FDA) has announced the fee rates for the Abbreviated New Drug Application (ANDA), Prior Approval Supplement (PAS), and Drug Master File (DMF) for fiscal year 2013, as mandated by the Generic Drug User Fee Amendments of 2012 (GDUFA). The rates, which include $51,520 for an ANDA and $25,520 for a PAS, will be published 60 days before the start of the fiscal year.