Resources, Guidelines, and Guidance Documents Directory

A pilot program to explore creation and testing of ePIs in regulatory procedures shows positive results.

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

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

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.

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.