There is something about being in the room that cannot be gleaned just by reading the minutes of the meeting. Even journalists must guess sometimes. I often get questions from trade-press representatives and about what the FDA means or is thinking and many times I must also guess! Anyway, the OGD and FDA discussed various […]
The minutes of the GDUFA IV negotiations meeting of December 17, 2025 (here) suggests so. With declining ANDA submissions and the intense dislike of the current GDUFA program fee, the FDA is proposing an alternative. Program fees are currently assessed based on a tier system that relates to the number of ANDAs that a firm holds. “Under […]
November 2025 output picked up as the OGD issued 59 full-approval actions and 25 tentative-approval actions in the month. The total of 84 approval actions is the highest since June 2025 when the OGD issued 89 approval actions. It’s also an improvement over October 2025’s output of 75, the first month of the new fiscal […]
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 today’s prepublication of the Federal Register (here), the FDA has announced the Generic Drug User Fees (GDUFA) for FY 2026. Every single one of the GDUFA for FY 2026 has risen, but the application fee rose more than 10% for a whopping increase of $36,327 for the submission of a new ANDA. In calculating the FY 2026 […]
For those of you who are required to pay the OMUFA manufacturer’s fees that were due on June 2, 2025 but failed to do so, your name may appear on the OMUFA Facility Arrears List (here). Remember, failure to pay the required fees will result in the FDA finding all of your OTC products misbranded. To […]
The FDA has published its Medical Device User Fees for FY 2025 (here) and the reason there are no surprises is that the fees all went up. The new fees are effective on October 1, 2024. The Federal Register Notice (FR) “provides information on how the fees for FY 2025 were determined, the payment procedures you should follow, […]
Rounding out the User Fee announcements, the Over-the-Counter Monograph Drug User Fee Program (OMUFA) announced its FY 2025 fees on July 31, 2024. The Federal Register Notice announcing the new fees can be found here. The update was only to the OTC Monograph Order Request (OMOR) fee rates – it did not include an update for the […]
The Biosimilar User Fee Program has announced the new FY 2025 fee schedule in the pre-publication of the Federal Register Notice (here). The base fee amount for the BsUFA program for FY 2025 is $51,058,823, which is adjusted for inflation (this year is calculated at 4.1881%); along with factoring in other required estimated expenses, this results in […]
The new Generic Drug User Fees for FY 2025 have been published (see Federal Register Notice here) and, with ANDA submission rates dipping, fees for submission of new ANDAs are soaring. The individual ANDA submission fee will be going up by $69,467 next year. Remember that October 1st (the beginning of FY 2025) is right around the […]
