Regulatory Affairs Editorial

  1. FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors 5/26/2026

    Discover five critical risks created by HALO's architecture and Elsa 4.0's expanded capabilities. Then, learn how to implement practical safeguards sponsors to implement immediately.

  2. Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials 5/26/2026

    BioAegis Therapeutics CEO Susan Levinson, Ph.D., talks about the role of partner and regulatory support in bringing their investigational immunotherapy into the clinic.

  3. FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control 5/22/2026

    ADRES Bio's Rivka Zaibel walks sponsors through the proper response to an FDA Form 483, emphasizing the need to show understanding and control of the situation.

  4. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

    FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

  5. Contracting For AI In Clinical Trials: Cybersecurity, Monitoring, And Risk Allocation (Part 3) 5/15/2026

    Leibowitz Law shares the third installment of its three-part series on contracting for AI in clinical trial operations. Part 3 picks up with cybersecurity, monitoring and validation, and risk allocation.

  6. Contracting For AI In Clinical Trials: Data Rights And Regulatory Compliance (Part 2) 5/15/2026

    Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 2 demonstrates why organizations must understand where it is used, how it interacts with data, and where the risks lie.

  7. Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1) 5/15/2026

    Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 1 outlines where AI appears in ClinOps and supporting technologies, and the questions companies and organizations should ask when AI touches data.

  8. The U.S. Clinical Trial Recruiting Pipeline Report – May 2026 5/12/2026

    This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from March 7 to May 1, 2026. 

  9. 5 Critical Risks With The FDA's Real-Time Trial Monitoring 5/8/2026

    Life science legal experts Kimberly Chew and Odette Hauke cover the FDA proof-of-concept real-time clinical trials (RTCTs) and expose five major issues that must be addressed before the pilot expands.

  10. Executive Order For Psychedelics 5/8/2026

    We caught up with Joseph Tucker, Ph.D., CEO of Enveric Biosciences, to discuss the executive order for psychedelics.