Blog Big Molecule Watch March 21, 2022

FDA to Hold Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

Tomorrow, March, 22, 2022, the FDA will host 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), the FDA contracted with independent third parties to assess the extent to which the Program for Enhanced Review and Transparency and Communication (“the Program”) improves the efficiency and effectiveness of 351(k) BLA reviews.  An interim report on the Program was published by Eastern Research Group, Inc. on December 2, 2020 and called for the final report to be published by June 30, 2022.  This meeting is meant to satisfy the FDA’s commitment to host a public meeting about the final assessment prior to September 30, 2022.   The meeting starts at 9:30 a.m. EST tomorrow.

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.”  The Q&A and public comment portion of the meeting is scheduled to begin at 11:35 a.m. EST.

We have previously posted on BsUFA rates for the 2022 fiscal year and the FDA’s notice of public meeting and request for comment relating to proposed recommendations for the reauthorization of the BsUFA for fiscal years 2023 to 2027.

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