There is something about being in the room that cannot be gleaned just by reading the minutes of the meeting. Even journalists must guess sometimes. I often get questions from trade-press representatives and about what the FDA means or is thinking and many times I must also guess! Anyway, the OGD and FDA discussed various […]
On February 9, 2026, the FDA approved modifications to the Risk Evaluation and Mitigation Strategy (REMS) program for the safe use of isotretinoin. The REMS program has undergone various changes since its initial inception in 2005. The shared program (brand and generic applicants) is designed to mitigate the risk of fetal toxicity from isotretinoin. The current […]
The gauntlet has been laid down and now it’s also been run through the FDA and courts will tell the tale. With Novo Nordisk’s (Novo) suit against Him and Hers, the issue of 503B outsourcing facilities compounding of copies of FDA-approved products may hang in the balance. FDA has apparently taken a hard line on […]
January saw the highest number of full ANDA approval actions in FY 2026 thus far at 59 (one more than the 58 from November) along with 19 tentative-approval actions for a total of 78 approval actions for the month. This figure places January as the second highest in total approvals, also behind November, for the first […]
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 […]
Today, the FDA again advised consumers to avoid purchasing and using Umary, a product marketed as a dietary supplement to treat pain; it contains the undeclared prescription drug ingredients diclofenac and omeprazole. The Agency first warned consumers about this product and another, similar product marketed as Amazy in June 2024 and reissued that warning in […]
Senator Rick Scott of Florida introduced the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (Clear Labels Act), which “would require prescription drug labeling to disclose the original manufacturers of generic drugs and APIs, giving patients, providers, and regulators clear, upfront information about a drug’s origins.” According to his website […]
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 […]
Great National Championship game last night right down to the wire! And today we’re halfway down to the wire on January approvals with actions reported through January 15th on the OGD’s daily approvals page. Thus far, the OGD has issued 25 full-approval actions and 7 tentative-approval actions for a total of 32 approval actions. If the […]
