FDA Launches Major Review of CGMPs

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

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

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

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

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.