Regulatory Affairs Editorial

  1. 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. 

  2. 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.

  3. 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.

  4. 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. 

  5. 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.

  6. Navigating FDA's New AI Systems: Practical Tips For Regulatory Success 1/19/2026

    AI-assisted reviews are changing FDA submissions. In part two of this series, discover how sponsors can address and even preempt regulatory and legal concerns.

  7. AI At The FDA: Legal Implications And Strategic Considerations For Drug Developers 1/19/2026

    AI-assisted reviews are changing FDA submissions. In part one of this two-part series, familiarize yourself with the FDA's use of AI and key legal concerns it raises.

  8. Site Management And Oversight Become Must-Haves For Successful Sites 1/15/2026

    Site management and site oversight are often used interchangeably in clinical research, but they mean different things. Explore their roles and importance in ensuring successful sites and trials.

  9. Could Moving To This Swiss Life Sciences Hub Be In Your Company's Future? 1/15/2026

    Basel Area Business & Innovation CEO Christof Klöpper discusses how the Basel Area Life Sciences Supercluster supports discovery through commercialization.

  10. How Should Scientific Focus Change In 2026? Researchers Weigh In 1/8/2026

    To kick off 2026, clinical researchers share how they think research should change in the new year.