Monday, November 8, 2010
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