FDA Offers Perspectives on Enhancements to the Application Review Model

Regulatory Guidances  •  U.S. FDA News

In a recent meeting, the FDA proposed modifications to the application review process for possible implementation into the Biosimilar User Fee Act (BsUFA). These modifications included establishing a review model similar to “the Program” initiated under the Prescription Drug User Fee Act (PDUFA). Highlights include a mid-cycle communication, a late-cycle meeting, and a review clock that begins on the 60-day filing date. The aim of such a change would be to promote the efficiency and effectiveness of the first cycle review process for biosimilars and minimize the number of review cycles necessary for approval.

The industry parties present explained that the proposed approach would need to be shared with their members for further input and that additional input would be provided to FDA at a later meeting.

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