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Dear Colleague,
The annual FY 2025 PDUFA program fee invoices were emailed on Thursday August 15, 2024. Please note that the invoices are only sent to firms with PDUFA user fee eligible products. If you do not receive your FY 2025 program fee invoice by August 19, 2024, and believe you should receive an invoice, please contact PDUFA User Fee staff at CDERCollections@fda.hhs.gov.
Please note that the FY 2025 payment is due on October 1, 2024.
The FY 2025 PDUFA fee rates were published in the Federal Register (FR) on July 31, 2024. The fee rates for FY 2025 are shown below:
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Fee Category
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Fee Rates for FY 2025
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Application
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Requiring clinical data
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$4,310,002
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Not requiring clinical data
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$2,155,001
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Program
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$403,889
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For more information regarding the FY 2025 fee rates, please see the FR notice available here or visit the PDUFA website.
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