Regulatory and Standard Setting Organizations

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

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

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

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

The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.