The GDUFA IV meeting held on January 7, 2026 (here) was a bit of a what-if session with the FDA introducing a few new concepts for consideration in the negotiation process. First, the FDA suggested waiving GDUFA facility fees for a three-year period for new domestic manufacturing facilities that break ground to manufacture generic drug products or […]
On Tuesday, the Association of Accessible Medicines (AAM) heralded the passage of the Q1/Q2 bill as a mechanism to speed certain generic drugs through the FDA approval system by making information on the qualitative and quantitative formulation of certain products available to generic manufacturers seeking approval a generic version of those products. AAM’s announcement here […]
The official Generic Drugs Program Monthly and Quarterly Activities Report for December 2025 has been published and it covers the complete first quarter (October to December) of FY 2026. Let’s take it by the numbers. In December 2025, the OGD approved 46 ANDAs, the lowest monthly total in the first three months of FY 2026. […]
The minutes of the GDUFA IV negotiations meeting of December 17, 2025 (here) suggests so. With declining ANDA submissions and the intense dislike of the current GDUFA program fee, the FDA is proposing an alternative. Program fees are currently assessed based on a tier system that relates to the number of ANDAs that a firm holds. “Under […]
The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) endorsed a new draft guidance on extractables and leachables in August 2025 that the FDA has since published for review and comment. The version published by the FDA is accessible at Q3E Guideline for Extractables and Leachables and includes Supporting Documentation: […]
In December, the third month of FY 2026, the number of unofficial approval actions fell significantly from those in the first two months, with the OGD issuing 41 full-approval actions and 13 tentative-approval actions for a total of 54. * December numbers are unofficial but should be close to final. The reasons are not obvious as […]
The official November 2025 OGD statistics are in the books and, as far as approvals are concerned, the OGD had a good month with 58 full approvals and 26 tentative approvals reported. Of the 58 full approvals, 6 were for first-time generics; however, only 6 (10%) were first-cycle approvals. This is one of the lowest […]
The FDA reports 27 full-approval actions and 9 tentative-approval actions through December 17, 2025 as posted on its daily (here) and all approvals (here) pages. This total of 36 full- and tentative-approval actions appears to be on the average side and, with the holiday coming up and the number of employees likely absent for vacation, it […]
We’ve been waiting for the first Generic Drugs Program Monthly and Quarterly Activities Report to be published for FY 2026, and it arrived sooner than expected! There’s at least one surprise and there are a few other interesting observations that we will discuss regarding new ANDA submissions for October 2025. But first, let’s talk about approvals. […]
On November 24, 2025, the FDA announced (here) that, following a comprehensive safety review, it has approved a reformulated ranitidine tablet, “marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during […]
