The Medical Device User Fees have been announced for FY2027. The Federal Register (FR) Notice can be found here: MDUFA FY2027. See the Lachman Blog for additional user fee blogs: GDUFA, BSUFA, PDUFA, ADUFA/AGDUFA, and Outsourcing. In addition to the inflation adjustment, which is always expected, further adjustments were required to meet the inflation adjusted […]
The Animal Drug User Fees for both Pioneer and Generics applications have been announced! The Federal Register (FR) Notices can be found here: ADUFA FY2027 and AGDUFA FY2027. See the Lachman Blog for additional user fee blogs: GDUFA, BSUFA, PDUFA, and Outsourcing. As a reminder, ADUFA V (FY2024-FY2028) allows for an adjustment for inflation and […]
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, […]
