Why Pharmacopoeia Compliance Is Difficult–An End-to-End Compendial Framework (PDF)

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

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

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

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

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.