Regulatory Affairs Editorial

1. The New FDA Era Of Radical Transparency And Pervasive Oversight 9/9/2025

   The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.

2. How Digital Twins Are Rewriting Clinical Trials 9/2/2025

   While the benefits of digital twins to accelerate clinical trials are undeniable, many questions about their use are still unanswered and go far beyond technology.

3. Insuring Global Clinical Trials: Navigating Risks Across Borders 8/28/2025

   Foreign clinical trials insurance is indispensable. Learn its features, its benefits, and why it's needed.

4. Where The FDA And EMA Stand On Digital Endpoints 8/22/2025

   In part two of this series on digital endpoints, consultant Anita Burrell reviews the extent of their regulatory acceptance and discusses how to ensure data produced from digital technologies satisfies regulators.

5. FDA's Elsa May Prompt Pharma To Rethink Regulatory Filings 8/13/2025

   AI expert Pradeepta Mishra of Beghou Consulting explains why pharmaceutical companies need to quickly evolve their regulatory strategies, authoring procedures, and governance frameworks in light of the FDA's new Elsa generative AI pilot.

6. Running Global Clinical Trials? PolyPid Shares Operational And Regulatory Insights 8/11/2025

   PolyPid shares its clinical trial journey across the U.S., Europe, and Israel, highlighting operational complexities, regulatory navigation, and the adaptability required to execute large-scale, global studies. 

7. Heart-In-A-Jar Organ Model Earns Regulatory Respect After 25 Years In The Making 8/7/2025

   Aligned with new FDA support for new approach methodologies (NAMs), Ronald Li, Ph.D, and Kevin Costa, Ph.D., share their story of creating Novoheart's mini heart organ model and discuss its current use in clinical trials.

8. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

   The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

9. What's Clinical Liability Insurance, And How Does It Work? 8/5/2025

   Life science insurance specialist Kristin Beaulieu explains why sponsors must develop a strategy for scaling their product liability insurance program, detailing two main product liability types to consider.

10. 5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution 7/29/2025

    Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.