FDA Perspectives: Revising the 1987 Industry Guideline The Development of FDA's Guidance on Aseptic Processing

The commitment will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple states.

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

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

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

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.