Inside FDA’s New Gene and Cell Therapy Guidances

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

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

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.

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

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.

The company’s state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, opened in February 2023.