Extended Review Timeline for Certain Applications under Proposed PDUFA V

May 21, 2012

The Prescription Drug User Fee Act (PDUFA) is due to be reauthorized by the end of September this year. Along with the usual increases in fees, the latest version of the act (PDUFA V) includes some new initiatives. One of these is a program for enhanced review transparency and communication which will apply to all New Molecular Entity (NME) New Drug Applications (NDAs) and original Biologics License Applications (BLAs). This includes applications that are submitted following a Refuse-To-File action.

Included in the program are specific meetings between the Agency and the Sponsor (e.g. pre-submission meeting, late-cycle meeting) as well as other communications. One very important change to this program affects the overall review timeline for a submission. For NME NDA and original BLA submissions that are filed by FDA under the program, the PDUFA review clock will begin at the conclusion of the 60 calendar day filing review period that begins on the date of FDA receipt of the original submission. What this means is that sponsors who submit NME NDAs and original BLAs on or after October 1, 2012 will have a two month longer review period than those submitted prior to that date. For sponsors looking at a filing date near the September 30th deadline, this new program provides additional incentive to file before the new timeline takes effect.

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