NDA Review Pilot Will Be Mandatory, Assuming Program Flies At All
The proposed review model for new molecular entity new drug applications and original biologics license applications remains under discussion along with several other Prescription Drug User Fee Act reauthorization issues.
You may also be interested in...
Interim and final assessments will help determine which parts of the new, longer application review help FDA take more first-cycle actions.
Final package expected to be published in late summer following clearance by the administration.
FDA and industry have reached agreement on four issues in the Prescription Drug User Fee Act reauthorization, including adjustments to risk-benefit policy and creation of a meta-analysis team.