PDUFA countdown

When FDA officials and representatives of the pharmaceutical and biotech industries meet in January to begin serious negotiations on reauthorizing the Prescription Drug User Fee Act, they will have relatively modest goals compared to the giant agenda hammered out in 1997, when FDA reform also was on the table.

FDA's primary focus will be stabilizing the rickety financial superstructure that the last PDUFA deal created, primarily by extracting commitments from industry for larger payments and obtaining greater flexibility in how the funds are spent. ...