- March 22, 2022
The Food and Drug Administration (FDA) is hosting a public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in in the Biosimilar User Fee Act.”
As part of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022, FDA committed to contracting with an independent third party to conduct interim and final assessments of the Program for Enhanced Review Transparency and Communication (“the Program”) for 351(k) Biologics License Applications (BLAs). The purpose of the assessments is to determine the extent to which the Program improves the efficiency and effectiveness of 351(k) BLA reviews.
The meeting will include (1) a presentation from an independent third-party contractor about its final assessment of the Program in BsUFA II, (2) an FDA response, (3) perspectives from external stakeholders, and (4) an open public comment period. Registrants will receive more information on how to provide open public comment when they register for the meeting.
This meeting is intended to satisfy FDA’s commitment to host a public meeting about the final assessment no later than September 30, 2022 (page 14 of the BsUFA II commitment letter).
- Agenda (PDF - 122 KB)
- Final Assessment (PDF - 1 MB)
- Interim Assessment
- BsUFA commitment letter
- FR notice