A Last Minute Approval Gives FDA User Fee Reauthorization

Courtesy of Apotex

At last! After nearly a year of committee hearings and political maneuvering, Congress finally has approved legislation to reauthorize FDA’s user fee programs for brand and generic drugs, biosimilars, and medical devices. The current programs expire with the close of fiscal year 2022 on September 30. Reauthorization will enable FDA to continue collecting application and facility user fees from industry for fiscal years 2023 through 2027, a 5-year period that begins October 1. Read more.