Negotiations over reauthorization of PDUFA are centering on FDA's proposals to normalize longer review times that it says are an inevitable result of drug safety requirements Congress created in 2007.

FDA is slated to formally present its final PDUFA V proposal to Congress in January 2012. But to meet legal requirements for public comment and to allow time for HHS and White House review, the agency is scheduled to complete negotiations with industry in January 2011.