On Monday morning at the Arizona Biltmore in Phoenix, Karim Mikhail opened the Alliance for Regenerative Medicine’s 2026 Cell & Gene Meeting on the Mesa. Mikhail became the permanent Director of FDA’s Center for Biologics Evaluation and Research in September. CBER leadership has turned over a lot this year, so the room was listening closely […]
The effect of publicly stated economic strategies cannot be overstated. These strategies drive the direction of the global life-science ecosystem. Good companies utilize Quality Risk Management (QRM) practices to integrate them into company-specific strategies. Great companies transform them into the proverbial competitive advantage, ensuring the right drug, at the right time, to the right patient. […]
The manufacturing landscape for cell and gene therapies is evolving rapidly, driven by the need for greater flexibility, efficiency, and proximity to patients. Two prominent models have emerged: Distributed Manufacturing (DM) and Point of Care Manufacturing (POC-M). Both approaches have unique benefits and challenges, particularly concerning quality control and regulatory compliance. This blog explores the […]
The Office of Generic Drugs reports that it approved 64 applications that were designated for competitive generic therapy (GCT) program. Since its inception, the program has approved a total of 186 (2 thus far in 2023) applications with the GCT designation. For the 2022 FY, OGD approved 69 ANDA that had GCT designation. Remember that […]
As the FDA notes, “Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy (CGT) designation under section 506H of the FD&C […]
