I’m sure you’ve heard this question and answer before – “Q: Would you like your pizza sliced into six or eight pieces?” “A: Only six pieces, please. I could never eat eight!” Well, the GDUFA IV negotiations and the subject of reallocation of GDUFA fees seem to be asking the same question. The entire pizza will […]
The user fees for outsourcing facilities (also known as compounding or 503B facilities) have been announced! The Federal Register (FR) Notice can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, PDUFA, MDUFA, and ADUFA. The establishment fee for a qualified small business and the re-inspection fee increased by […]
Both pioneer and generic animal drug user fees have been announced! The Federal Register (FR) Notices can be found here: ADUFA FY 2026 and AGDUFA FY 2026. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, PDUFA, MDUFA, and Outsourcing. I’m sure that pioneer/innovator animal health companies are in a bit of shock over […]
The Medical Device User Fees (MDUFA) have been announced for FY 2026! The Federal Register (FR) Notice can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, PDUFA, and ADUFA. Across the board, for both standard and small businesses, fees increased by 7.1% with the exception of establishment fees, which increased […]
The FY 2026 Biosimilar User Fees (BsUFA) have been announced! The Federal Register (FR) Notice can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, PDUFA, MDUFA, and ADUFA. BsUFA fees are established under BsUFA III, effective for FY 2023 to FY 2027. As in FY 2024 to FY 2025, the Biological Product Development (BPD) fees did […]
The FY 2026 user fees have been announced! The Federal Register (FR) Notice related to Prescription Drug User Fees (PDFUA) can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, MDUFA, and ADUFA. The fees increased by 8.6% for applications, which is a larger increase when compared to that from […]
Today, in the pre-publication of the Federal Register (here), the Agency announced a notice of public meeting to receive comments and discuss the material negotiations that have taken place between the industry stakeholders and itself. The notice provides an interesting historical look at the evolution of the PDUFA program since its initial 5-year iteration in […]
After a stop-and-go where the FDA pulled back an earlier Federal Register (FR) notice due to an issue with the calculations, the new PDUFA fees have been announced in a pre-publication of the FR here. So, this ends the announcements for the 2022 UFAs and you can take that to the bank! The new PDUFA […]
