FDA Generic Drug API and FDF Facilities User Fees

FDA Announces Generic Drug API and FDF Facilities User Fees for FY 2013

In a Federal Register notice set to be published January 17, 2013, FDA established the GDUFA fee rates for active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities.  According to the docket, the domestic FDF facility fee will be $175,389 and the domestic API facility fee will be $26,458. The foreign facility fees for each are $15,000 more. Combined, these fees will make up a percentage of the remaining $299,000,000 of the total GDUFA fee revenue FDA expects to collect in 2013.

For more information on the history of the Prescription Drug User Fee Act (PDUFA) and the Generic Drug User Fee Act (GDUFA), please see our relevant webinars:

Posted by Nick Fleischer, Vice President. For more information, please contact Nick at nick.fleischer@weinberggroup.com.