The FDA announced today (here) that FY 2026 prescription drug program fee invoices for New Drugs have been sent out to firms via email. The Agency asks firms to review the invoices promptly and report any discrepancies that might arise.
Prescription drug program fees must be paid for up to five strengths of a product approved in a new drug application. The current program fee is set at $442,213; multiply that by the number of different strengths in an application (which can be up to five) and be sure to pay the freight by the due date of October 1, 2026.
For more information on FY 2026 user fee rates, please see the Federal Register Notice here or visit the PDUFA webpage on the FDA’s website here.
Invoices from the FDA have been mailed today (August 18th). If you do not receive your invoices by August 22, 2025, the FDA recommends contracting the Agency at CDERCollections@fda.hhs.gov.
As fees from the FDA continue to rise, this additional pressure will certainly place even more pricing pressure for drugs. Time will tell how this will impact the industry and consumers.
