Fiscal Year (FY) 2023 Notification of Annual BsUFA Fees

If your email program has trouble displaying this email, view as a webpage.          Fiscal Year (FY) 2023 Notification of Annual BsUFA Fees In preparation for FDA's annual FY 2023 BsUFA invoices, the Notification of Annual BsUFA Fees correspondence was emailed on June 10, 2022. Please submit your response by June 25, 2022. If you have any questions, please contact us at CDERCollections@fda.hhs.gov. If you plan to discontinue participation in the BPD program prior to FY 2023, you must submit a formal written request to the regulatory project manager for the pre-IND or IND no later than August 1, 2022, pursuant to section 744H (a)(1)(C) of the Federal Food, Drug and Cosmetic Act (21 U.S.C §379j-52(a)(1)(C)). Please send a courtesy copy to CDERCollections@fda.hhs.gov. Requests received after August 1st will result in the firm receiving an annual BPD invoice for FY 2023.  **Please note: This update is only applicable to companies that have BsUFA user fee eligible biosimilar biological products.**   Read More

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