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 […]
Lachman Consultant Services, Inc. is proud to announce its participation in the 11th Global Pharmaceutical Quality Summit (GPQS), hosted by the Indian Pharmaceutical Alliance (IPA) — one of the premier global forums for advancing pharmaceutical quality, regulatory excellence, and operational innovation. The Summit will take place over two days, bringing together industry leaders, regulators, experts […]
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 […]
Traditionally, user fee negotiations, whether for PDUFA, GDUFA or BSUFA, have maintained that the negotiations are essentially for fee-for-service contracts. What this means is that the industry provides fees and the FDA provides services for those fees. The negotiations usually end with the commitment letter and any statutory changes that result from the negotiations. For […]
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 FDA issued a guidance document “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations” (September 2025) (here) that focusses on the analytical approaches to be employed for comparative testing to demonstrate similarity between the proposed recombinant protein product and the reference (recognizing that the tools within the guidance could be applied […]
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 […]
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 […]
