With the introduction of two draft guidances, FDA has set new performance goals for the regulatory submission process for generic drug manufacturers. Over the course of a three-year period, the agency will begin to implement these goals and eventually reach a point where almost all submissions for prior approval supplements (PAS) will receive action within six months and Abbreviated New Drug Application (ANDA) amendments will receive action within ten months. By promising expedited response times, FDA is hoping to motivate generics manufacturers to submit quality applications with minimal revisions.
The new performance goals will begin to affect regulatory applications with a submission date on or after October 1, 2014. FDA response timelines will be determined by a three-tier system that will divide any necessary amendments into groups based on complexity.