Extending QMS to Contract Partners

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.

Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.

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

On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.

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