The Part 11 Controversy: A Root Cause Analysis and Science-Based Solutions

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.

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

The European Commission has approved Novo Holdings' acquisition of Catalent, which includes the related sale of three manufacturing sites to Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

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

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.