GMP Update: Reducing Obstacles to Innovation

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

In this episode, David Tisi and Reenal Gandhi provide expert insights into advances and innovations changing the drug dosage form landscape.

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, discusses point of care and patient manufacturing with Pharmaceutical Technology editor Jill Murphy.

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.