Regulatory Affairs Editorial

  1. Don't Let The Nocebo Effect In Psychedelic Trials Become A Regulatory Problem 3/23/2026

    When a patient feels no effect or a worsening effect because a known treatment effect was or wasn't experience, that's the "nocebo" effect. Strategic Advisor Jama Pittman discusses how this effect could impact regulatory reviews.

  2. How Important Are Medical Monitors Under ICH E6(R3)? 3/20/2026

    Discover how medical monitor-led implementation of ICH E6(R3) outperforms operations-only models across six critical performance dimensions.

  3. Are You Liable? What All Clinical Stage Companies Should Understand About Risk Disclosure 3/20/2026

    Barnes & Thornburg partner Seth Mailhot provides a primer on risk disclosure and how sponsor companies can prepare for and mitigate issues that might arise.

  4. Patient-Powered Drug Trials Are Getting The FDA Greenlight 3/12/2026

    Patient- and parent-led drug development is on the rise, with the latest effort securing FDA clearance for a gene therapy trial. Yet, they are largely invisible. Buffalo Initiative plans to change that.

  5. FDA's Elsa AI Switches From Claude To Gemini: What Sponsors Need To Know 3/12/2026

    Forced to cease using Anthropic's Claude for its Elsa generative AI assistant, the FDA is switching to Gemini. Legal experts Kimberly Chew, Esq., and Michael Yang, Esq., explain the implications for trade secrets and data security risks.

  6. When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down 3/11/2026

    Regulators want one thing during inspections — to see how the data flows, says Just In Time GCP's Donna Dorozinsky. Here, she explores the importance of data oversight and where sponsors sometimes go wrong.

  7. How Deep Learning Is Changing Clinical Trial Design, Execution, And Analysis In 2026 3/10/2026

    Deep learning is reshaping clinical trial design, execution, and analysis. Learn how to deploy it safely, measurably, and at scale with help from life sciences consultant and MIT industry advisor Partha Anbil.

  8. The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development 3/9/2026

    Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.

  9. 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. 

  10. 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.