As part of its commitments in PDUFA V, FDA has established a new review program (“the Program”) to promote greater transparency and increased communication between the FDA review team and the applicant on the most innovative products reviewed by the agency. The Program applies to all new molecular entity new drug applications (NME NDAs) and original biologics license applications (BLAs) that are received from October 1, 2012, through September 30, 2017.
The goals of the Program are to increase the efficiency and effectiveness of the first review cycle and decrease the number of review cycles necessary for approval so that patients have timely access to safe, effective, and high quality new drugs and biologics
The key features of the Program include:
new opportunities for communication between applicants and the FDA review team during the agency’s review of the application
additional review clock time for the agency to meet with applicants during review as well as to address review activities that occur late in the review cycle for these highly complex applications
an interim and final assessment that will evaluate whether the parameters of the Program have achieved the intended goals.
This page contains information relevant to the assessments as well as other communications related to the Program. Additional details about the Program can be found in Section II of the PDUFA V Commitment Letter (PDF - 240KB).
Assessment of the Program
Final Assessment of the Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs in PDUFA V(PDF - 2.8MB) Interim Assessment of the Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs in PDUFA V(PDF - 4.3MB)
- Statement of Work for Assessment of the Program (PDF - 225KB)
- Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in PDUFA V; Request for Comments
Federal Register Notice (7/6/2012)