The FDA has finalized the Guidance for Industry titled Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (here). The final guidance is essentially the same as the draft of the same name issued on October 22, 2022 with the exception of minor editorial changes to increase clarity. The use of classic […]
February was a short month with a big number as the OGD issued 64 full-approval actions and 25 tentative-approval actions for a total of 89 approval actions. This represents both the highest number of approvals thus far this fiscal year and the most total approval actions since January 2025, when there were 90. With ANDA […]
As is the case with most negotiation sessions, no agreements were made at this time on the issues discussed. This is a back-and-forth process and the norm as negotiations proceed; the ultimate FDA decision-makers must weigh in on the issues prior to agreement. The full minutes of the meeting can be found here, and some […]
The newly named Board Chair of the Association of Accessible Medicines (AAM), Bob Hoffman, Chief Commercial Officer of U.S. Generics for Lupin Pharmaceuticals, provided his view of the current state of the generic and biosimilar industry and some of the issues he is concerned about. Bob noted that the “current system need a course correction” […]
Today, the Office of Generic Drugs announced the issuance of 98 Product-Specific Guidances (PSGs). The guidances can be accessed here. In an email announcing the availability of the newly issued guidances, the FDA said: “Today’s batch of 98 PSGs (31 New and 67 Revised) contains: 68 PSGs for products with no approved ANDAs (including 31 complex products) 46 PSGs […]
The Association of Accessible Medicines (AAM) continued Day 1 with a discussion of what’s happening on Capitol Hill and how we can be working to position industry priorities with policymakers to make the most positive impact on patient access. The session was conducted as a fireside chat hosted by Mark Ratner, Senior Vice President, Government Affairs, […]
We now have official statistics for one-third of FY 2026. While the number of full approvals hit a high (by one) for FY 2026, the number of new ANDA receipts in January were disappointing. Let’s take a look at the most significant statistical metrics for the current report. As far as FDA actions, the OGD fully approved […]
Well, here we are, just a tad over halfway through the shortest month of the year. That’s right, there are only twenty-eight days in February, and one of them is a holiday. This February there are only nineteen business days during which OGD approvals can occur. Today, we can report on approvals posted through February […]
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 […]
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 […]
