FDA Seeks Comments on Evaluation of Proposed New Model for Reviewing BLAs

Regulatory Guidances  •  U.S. FDA News

The FDA announced that it is soliciting public comments on the statement of work for the assessment of its proposed new model for the review of original Biologics License Applications submitted under section 351(k) of the Public Health Service Act.

Last fall, we reported on the FDA’s performance goals for the reauthorization of the Biosimilar User Fee Act for fiscal years 2018 – 2022.   The FDA’s goals letter details its proposal for its new BLA review model, the “Program for Enhanced Review Transparency and Communication for Original 351(k) BLAs” (the “Program”).  According to the FDA, the Program’s goal is to “improve the efficiency and effectiveness of the first-cycle review process by increasing communications during application review.”  One of the FDA’s recommendations is for the Program to be “continuously assessed” by an independent contractor.  The statement of work details the proposed objectives and scope of this assessment.

The FDA will be providing a 30 day period for public comments on the statement of work.  The FDA’s announcement is scheduled to be published in the Federal Register on June 29, and comments will be accepted on the public docket (FDA-2017-N-3199) through a projected closing date of July 29.

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