Near-Infrared Spectroscopy as a Process Analytical Tool

The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.

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

The company is recalling one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules because some bottles may contain empty capsules.

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

FDA's approval of Hikma Pharmaceuticals’ liraglutide injection makes this product the first generic version of Victoza, a GLP-1 receptor agonist.

Challenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.