PDUFA Communications Hurt By Sequestration As Late-Stage Meetings Begin

The first sponsors with applications navigating FDA’s PDUFA V review system are nearing their final stages, but it remains too early for industry to tell how well the program is working, even as the time approaches to begin work on the next reauthorization.

The centerpiece of the reauthorized prescription drug user fee program, which launched Oct. 1, 2012, is the longer review system for new molecular entity and novel biologic applications