New Generic Drug Review Policies Raise Eyebrows Of Former FDA Officials

A former FDA generic drug chief told Inside Health Policy he expects FDA to receive some backlash from industry on its new plan to prioritize generic drug submissions with metric goals and those flagged for priority review because the policy could leave out the majority of submissions filed during the first two years of the Generic Drug User Fee Act. The issue of how to prioritize generic drug review likely will emerge as a new talking point in the...