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

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

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

Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.

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

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

The Biotechnology Innovation Organization’s new membership survey said that 90% of US biotech companies rely on imported components for at least half of their FDA-approved products.