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 […]
Section 744M of the FD&C Act (21 U.S.C. 379j-72), authorizes the FDA to assess and collect: (1) facility fees from qualifying owners of OTC monograph drug facilities and (2) fees from submitters of qualifying OTC Monograph order requests(OMORs). OMOR fee rates for Fiscal Year (FY) 2024 were published on September 12, 2023 (see blog post […]
The Food and Drug Administration (FDA) has announced the fiscal year (FY) 2024 rates for the establishment and reinspection fees related to entities (503B registered facilities)” that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and […]
The schedules for the 2024 Biosimilar User Fees (BsUFA) (here) and Medical Device User Fees (MDUFA) (here) have been posted on the Federal Register prepublication page and are scheduled for final publication on August 28, 2024. BsUFA Fees The Biosimilar User Fee Amendments of 2022 (BsUFA III) authorize the FDA to assess and collect user fees for […]
The PDUFA user fees all rose, not much of a surprise! However, we are now getting into some serious money to submit a new NDA. These fees could (in some instances) deter smaller applicants from entertaining NDA submissions as they might price them right out of the market. And if it is not the NDA […]
On the Federal Register (FR) prepublication page today, the FDA outlined the new fee schedule for generic drugs under the GDUFA program for FY 2024. Make sure you have a bottle of Maalox nearby before you read the rest of this blog as the increases, especially for the program fees, might cause you some agita. Generic […]
This morning, the FDA published the OTC User Fee rates for FY 2023 in a Federal Register notice (here); these rates cover fees for OTC manufacturing facilities (MFD), contract manufacturing organizations (CMO), and OTC monograph order requests (OMORs) for which there are tier 1 and tier 2 requests. A comparison of the first three fiscal years is presented […]
