PDUFA VI Aims to Minimize Administrative Obstacles

The FDA hopes to abandon its one-size-fits all approach to reviewing new molecular entities in the next iteration of PDUFA.

That and many other changes appear in the agency’s proposal for performance goals and procedures to follow for the next version of PDUFA, which is expected to take effect when the current version of the five-year authorization expires in September 2017.

Under the agency’s proposal covering fiscal years 2018 to 2022, sponsors of new molecular entities can propose their own plan for communicating with the FDA. Under the current system, communication exchanges occur under a set system, with pre-submission meetings, mid-cycle communications, and late-cycle meetings.