In the realm of pharmaceuticals, navigating the intricate landscape of facility and Quality Management System (QMS) remediation following FDA enforcement actions demands precision, foresight, and a commitment to sustainable change. When faced with regulatory scrutiny, it is imperative for companies to not only address the identified issues but also to comprehensively understand the root causes […]
The last blog that we drafted on this topic, The Curious Case of the Late Cycle Amendment under GDUFA III, was posted last summer (here). As a quick refresher on what we covered, the GDUFA III Commitment Letter (here) included several new enhancements to the Generic Drug User Fee Program, one of which was the inclusion of […]
The FDA received no comments on the draft guidance titled Facility Readiness: Goal Date Decisions Under GDUFA, and, as such, has finalized the guidance with only minor editorial changes. The advance prepublication of the Federal Register Notice (here) notes, “[U]nder the commitment letter related to the GDUFA authorization for fiscal years 2018 through 2022 (under […]
A sneak peek at the Office of Generic Drugs’ May 2024 approval actions should put a smile on the industry’s face as the OGD hit the highest number of total approval actions so far this FY in May. The OGD issued a total of 84 approval actions last month, consisting of 72 full-approval actions and […]
A May 28, 2024 review article by Skylar Jeremias titled, “New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching” (here), supports the fact that switching between biologics and biosimilars or from one biosimilar to another does not present a problem. The article states “[S]ince the July 2022 publication of the first systematic review of biosimilar-to-biosimilar switching, the European […]
Today, the FDA issued twenty-six new and six revised Product Specific Guidances (PSGs) (here). PSGs provide the Agency’s current thinking on acceptable methods for demonstrating bioequivalence between the Reference Listed Drug or the Reference Standard designated by the Agency (if the RLD is no longer available) and the proposed generic product. These latest PSG additions […]
At the Center for Drug Evaluation & Research (CDER) Small Business Industry Assistance (SBIA) meeting held on April 25th, titled “Facilitating Generic Product Availability Through Product-Specific Guidances (PSGs) for 2024,” the FDA presented some updates regarding the FDA Dissolution Database. Dr. Leah Falade, Senior Pharmacologist in the Office of Pharmaceutical Quality, CDER, was the presenter in Session 6. […]
The number of reserve samples required by current regulations has been a sore subject for both NDA and ANDA sponsors as well as testing facilities as the cost and storage requirements for the required reserve samples of both test and reference product was overly burdensome. Now, after twenty years of concern expressed by the industry, […]
A month and half after the close of the January books, we now get a look at the output and incoming workload of the Office of Generic Drugs for January 2024, the fourth month of Fiscal Year (FY) 2024. I will provide some of the highlights of the Generic Drugs Program Monthly Report, but you […]
The OGD’s approval actions for the month (at least those posted by March 5, 2024) are in line with the first four months of this fiscal year. There were 52 full approval actions and 11 tentative approval actions for a total of 63 approval actions. While we have not seen January’s official statistics yet, the […]
