- January 27, 2021
The Food and Drug Administration (FDA) is hosting a public meeting entitled “Interim 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 interim 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 comments prior to the meeting.
This meeting is intended to satisfy FDA’s commitment to host a public meeting about the interim assessment no later than March 2021 (page 14 of the BsUFA II commitment letter).
|BsUFA II Interim Assessment_Public Meeting Agenda.pdf||pdf (132.66 KB)|