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PDUFA 2007 – New Submisison Fees for 505(b)(2) Applications

Congress just passed the Food and Drug Administration Amendments Act of 2007.  Most of us in 505(b)(2) drug development will think of it as the PDUFA 2007 (Prescription Drug User Fee Amendments of 2007).  This amendment covers the period from 2008-2012 (plus, to circumvent the rush experienced with this re-authorization, provisions for an extra 3 months into FY 2013).

Congress authorized charging $50 million more than requested by FDA or pharma.  Clearly, this will result in higher fees by pharma.  Once signed by the President, FDA will compute the actual charge per application.  Stay tuned…