Risk Management Shapes FDA Policies and Practices

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

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

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

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

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue.

A total of 13 drugs were granted recommendation for market authorization at EMA’s CHMP June 2025 meeting.