Regulatory Affairs Editorial

  1. The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board 3/5/2026

    Tufts CSDD’s Beth Harper shares findings from the org's latest Impact Report and discusses how companies might better define risk, measure success, and understand central monitoring. 

  2. FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs 3/4/2026

    The FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development. Jessica Cordes summarizes the latest from the FDA and offers advice for small biotechs.

  3. Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease 2/19/2026

    The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.

  4. U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact 2/18/2026

    Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.