Regulatory Affairs Editorial

  1. 2 Ways To Overcome The Challenge Of Developing Neurological Rare Diseases Drugs 6/16/2025

    GRIN Therapeutics CEO Bruce Leuchter, MD, explores how integrating new business models and technological advances will be crucial to developing new treatments for rare neurological disorders.

  2. Hidden Compliance Risks In Start-Up That Could Derail Your Clinical Trial 6/13/2025

    Kulkarni Law Firm Senior Attorney Edye T. Edens explores the risks embedded in clinical trial start-up activities, such as site activation, contract execution, delegation of responsibilities, and cross-border data flows.

  3. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

    The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

  4. Insights From 250+ Regulatory Inspections 6/10/2025

    Elisabeth George, who has led more than 250 FDA inspections, shares practical advice for hosting audits — including preparation tips, team coordination, live documentation, and knowing exactly when to speak.

  5. U.S. Tariffs And Their Tenuous Impact On Clinical Trials 6/10/2025

    RSM US LLP Life Sciences Senior Analyst Amanda Laskey discusses Trump administration tariffs and how they're expected to impact the pharma world, specifically clinical research.

  6. 6 Tips To Ensure Revenue Integrity And Compliance In Clinical Operations 6/9/2025

    Discover the importance of Medicare Coverage Analysis (MCA) and the rules of National Coverage Determination (NCD) in establishing financial security and regulatory adherence in clinical operations.

  7. Everything To Know About Long-Term Data Collection For Cell And Gene Therapy Trials In The EU 6/4/2025

    Discover how to secure uninterrupted access to long-term trial data for CAR-T therapies by participating in the European Society for Blood and Marrow Transplantation (EBMT) CAR-T Data Collection Initiative. 

  8. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

    The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

  9. Why Perfect Clinical Trial Data Is A Dangerous Myth 6/2/2025

    Former FDA inspector Kara Harrison reveals clinical trials fail due to overcomplex designs, checklist-driven monitoring that misses critical issues, and lack of focus on what actually matters for patient safety and data integrity.

  10. Here's Your 483 — And Your Hug 5/27/2025

    Former FDA inspector Tracey Harris shares what clinical sites get right, what they botch completely, and why inspection readiness is about more than coffee, binders, or bluffing.