Secretary Kennedy has basically accused much of the FDA and other parts of the HHS organization of being corrupt. One of his stated goals was to root out corruption. However, he never explicitly defined what the corruption was or identified any individual accused of it. Instead, he spoke of the revolving door where FDA employees […]
Today, the FDA posted its August 2025 monthly statistical report, and with FY 2025 ending on September 30, 2025, we’re only one update away from the official numbers for the full fiscal year. The August update indicates that the OGD did, as previously reported, fully approve 47 new ANDAs and (at OGD official count for the monthly […]
According to a post on NOTUS (here), FDA Commissioner Marty Makary, M.D. says that he has the “Agency ‘Exempted’ from possible shutdown RIFs.” Well, after the hit that FDA staff took over the last eight months, this should be good news for current FDAers. (That is, if you can accept and believe what you read.) […]
An Association for Accessible Medicines release (here) reports that the AAM “thanked the House Energy and Commerce Committee for marking up Q1/Q2 legislation previously introduced by Representatives by Congressmen [sic] Dunn of Florida and Mullin of California. The bipartisan and bicameral legislation was included in the 2024 year-end spending bill and was reintroduced this Congress.” […]
As discussed in a recent Lachman blog Revised Q1 Draft Stability Document Issued by FDA, the draft guidance titled Q1 Stability Testing of Drug Substances is a consolidated revision of ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C. This draft guidance provides guidance on product categories, such as advanced therapy medicinal products, vaccines, and other […]
The FDA’s current drug shortage list (here) contains 93 entries with 10 of those entries being for drug shortages that are resolved. This means that the FDA currently lists 83 drugs that are actually in shortage. The American Society of Health-Systems Pharmacists (ASHP) listing (here) currently reports 222 drug shortages. Why is there such a […]
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 […]
