If your email program has trouble displaying this email, view as a webpage. FY 2022 PDUFA Program Fee Invoices and Rates Dear Colleague, The fiscal year (FY) 2022 PDUFA program fee invoices were emailed on Friday, August 20, 2021.  Please note that the invoices are only sent out to firms which have PDUFA user fee eligible products. If you do not receive your invoice by August 25, 2021 and believe you should receive a program fee invoice, please contact PDUFA User Fee staff at CDERCollections@fda.hhs.gov.  The FY 2022 PDUFA fee rates were published in the Federal Register (FR) on August 16, 2021. The fee rates for FY 2022 are shown below: User Fee Type 2021 2022 Application Fee - Clinical Data Required $2,875,842 $3,117,218 Application Fee - No Clinical Data Required $1,437,921 $1,558,609 Program Fee $336,432 $369,413 For more information regarding the FY 2022 fee rates, please see the FR notice available here or visit the PDUFA website. Read More

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