Regulatory Affairs Editorial

  1. FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now 2/13/2026

    On December 15, 2025, the FDA finalized its guidance Enhancing Participation in Clinical Trials, formally updating expectations for enrollment and trial design. Here's what you can do now.

  2. How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2) 2/12/2026

    Learn how to comply with the EU AI Act when AI is used in GCP-critical eTMF contexts in part two of this series by Donatella Ballerini.

  3. How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1) 2/12/2026

    Learn how the EU AI Act reshapes the regulatory treatment of AI-enabled eTMF systems with consultant Donatella Ballerini.

  4. The FDA Calls For Culturally-Informed Research, But What Do We Understand About The Sikh Community? 2/9/2026

    Despite the size and visibility of the community — and the call for diverse patient research — there remains a gap in available health data specific to the Sikh community in the U.S.

  5. Becoming A Backbone Therapy: Lessons Learned With Actuate Therapeutics 2/5/2026

    CEO Dan Schmitt discusses the pursuit of a backbone therapy and how Actuate's current and planned trials are structured to confirm that potential.

  6. Why Dr. Robert Califf Isn't Pulling His Punches Anymore 1/30/2026

    In this exclusive video interview, former FDA commissioner Robert Califf, MD reflects on quality, risk aversion, misinformation, and why clinical trials need sharper focus — not more data. 

  7. The U.S. Trial Advantage Is Eroding 1/30/2026

    Once the go-to location for trials, the U.S. is now seeing competition from APAC, driven by political, economic, and workforce pressures domestically and rapid growth abroad.

  8. 4 Factors Changing The Way CRAs Monitor Trials 1/28/2026

    The way CRAs monitor is about to change. Regeneron's Patrick Floody discusses these four factors that will influence it.

  9. 3 Clinical Research Attorneys Talk 2026 Trends 1/23/2026

    Three life sciences legal experts share what they see happening in the year ahead — and what should remain firmly in the past. 

  10. The "One-Trial" Trap: Why 2026's FDA Efficiency Push Actually Doubles Your Operational Risk 1/22/2026

    When it comes to the FDA's new "one-trial" shift, researcher Johnathon Anderson, Ph.D., warns: Do not confuse efficiency with leniency. Here, Anderson offers three factors to consider when adapting to new FDA trial expectations.