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 […]
On Day 2 of the Generic Drugs Forum (GDF), there were a couple of sessions on Drug Master Files (DMFs) that provided some helpful information. The first presentation, from Dr. Jayani Perera, Senior Chemist in the Division of Product Quality Assessment (DPQA) XIX, provided some insight into the GDUFA III impact on DMF Assessments and DMF Prior Assessments (watch […]
On Day 1 of the Generic Drug Forum, the topic of submitting a Request for Reconsideration (RfR), as first provided for in GDUFA II and updated in GDUFA III, was presented. The FDA’s Office of Generic Drugs (OGD) had two presentations on this topic, one from Joe Shin, PharmD, and one from Dr. Yi Zhang. In his presentation, Dr. Shin […]
Revision 2 of the FDA Guidance for Industry “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” was published on January 6, 2025 and it finalizes the previous draft version. This is a procedural guidance that applies to medical products regulated by CDER, CBER, CDRH, […]
If you received one or more reminder emails in November 2024 asking your firm to submit 2023 CARES Act reports, you are not alone. In 2024, the FDA emphasized the importance of CARES Act reporting and the Agency’s need for the data contained in those reports at several conferences, but there have continued to be […]
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 […]
