The pharmaceutical supply chain is no longer just a chain of physical materials, but rather a complex series of data, data-based decisions, and delegated responsibilities for that data. FDA’s CDER FY2024 Site Catalog reported 4,619 manufacturing sites globally, reflecting the broad scale of the regulated manufacturing network supporting the U.S. drug supply. Within that network, […]
The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post. Here are some of the proposed rules that caught my attention: Current Good Manufacturing Practice for Outsourcing […]
In a previous blog posted on April 16, 2026 (here), we discussed the announcement from FDA regarding an upcoming meeting of the Pharmacy Compounding Advisory Committee to be held on July 23-24, 2026, focused on the inclusion of some active ingredients on the permitted pharmacy compounding list. That post identified seven peptide active ingredients that […]
Analytical method validation performed in industry is undergoing a significant transformation—and if your analytical method validation protocol templates haven’t evolved, now is the time to take a closer look. The United States Pharmacopeia (USP) has proposed a revision to USP <1225>, Validation of Analytical Procedures. This update brings the chapter into closer alignment with ICH Q2(R2) […]
June was a hot month for most of the East Coast, and it was a hot month for ANDA approval actions too (albeit but just a tad cooler than May’s numbers). OGD managed to issue 76 full approval actions and 17 tentative approval actions for a total of 93 approval actions in June. The 76 […]
In a June 25, 2026 notice on data integrity in medical devices, the FDA takes note of “an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors. This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical […]
The FDA approved the first generic of Baloxavir Marboxil tablets 40 mg and 80 mg for Norwich Pharmaceuticals Inc., on June 17, 2026. It is the generic equivalent of Genentech’s Xofulza approved for: Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 […]
The new draft guidance “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products” (here) provides the industry with a foundation for providing one adequate and well-controlled study with appropriate confirmatory supporting data to satisfy the Agency’s requirement for demonstrating safety and efficacy. While this may, on its face, appear to be a boon […]
The OGD released its May 2026 Generic Drugs Program Monthly and Quarterly Activities Report (here) late Tuesday evening. In our blog covering unofficial May mid-month approval actions (here), we surmised that the final ANDA approval numbers would be significantly lower than the May numbers when the official metrics came out and we were right… they […]
Over the last six to eight months, the FDA’s activity regarding compliance with the required posting of ongoing and completed clinical trials has significantly increased, as evidenced by the issuance of multiple warning letters and letters of non-compliance to sponsors and/or principal investigators. To assist responsible parties in complying with the requirement to post on […]
