Changes and Challenges for CDER

Poor API quality may often lead to delays in production and a shortage of supply.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.