Regulatory Affairs Editorial

  1. Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing 3/27/2026

    Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.

  2. Elsa's AI Model Migration: Technical, Compliance, And Regulatory Risks For Sponsors (Part 2) 3/26/2026

    In the second part of their series on Elsa AI model migration, Kimberly Chew, Esq., and Michael Yang, Esq., analyze the risks to compliance and data residency, as well as the integrity of the regulatory record.

  3. From Real-World Data To Real-World Impact: Building The Evidence Capability Pharma Actually Needs 3/25/2026

    Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.

  4. Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials 3/24/2026

    Zymeworks CMO Sabeen Mekan, MD, explores how scientific gains in ADC therapies have influenced first-in‑human trial design.

  5. A Clinical Machine Learning Operations (MLOps) Maturity Framework For Biopharma 3/24/2026

    Pharma has invested substantially in machine learning applications, but investment in the operational infrastructure — the MLOps layer — has lagged. The time to build that infrastructure is now — not after your next trial fails.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.