Keep an eye on your mailbox and get ready to open your checkbook! FDA says:
“The annual FY 2027 PDUFA program fee invoices were emailed on Tuesday, August 18, 2026. Please note that the invoices are only sent to firms with PDUFA user fee eligible products. If you do not receive your FY 2027 program fee invoice by August 21, 2026, and believe you should receive an invoice, please contact PDUFA User Fee staff at FDAUserFees@fda.hhs.gov.”
With this announcement, the FDA reminds sponsors that the FY 2027 program fees are due on October 1, 2026. The program fee is assessed on certain approved products (section 736(a) of the FD&C Act) for FY 2027 is $416,857. “An applicant will not be assessed more than five program fees for a FY for prescription drug products identified in a single approved NDA or BLA (see section 736(a)(2)(C) of the FD&C Act). Applicants are assessed a program fee for a FY for user fee eligible prescription drug products identified in a human drug application approved as of October 1 of such FY. Additionally, applicants are assessed a program fee for a product that is not a prescription drug product on October 1 because it is included in the discontinued section of the Orange Book or the CDER/CBER Billable Biologics List on that date, if the product becomes a fee-eligible prescription drug product during the FY.” (See the original FR Notice from July 30, 2026 here.)
