Regulatory Affairs Editorial

  1. Trends In Rare Disease Trials: Recommendations 10/24/2025

    In the third article of this series, analyst reveal their top 6 recommendations for designing selection criteria and selecting solution options to optimize rare disease research outcomes.

  2. Regulatory Pathways — With Real-Life Examples — For Successful CGT Clinical Trials 10/24/2025

    Discover the most effective regulatory pathways used to support CGT development, including two real-life examples.

  3. FDA Vs. MHRA Vs. EMA: Differences In Externally Controlled Trials 10/23/2025

    As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones.

  4. Clinical Trials At A Crossroads 10/22/2025

    At DPHARM 2025, McKinsey’s Gaurav Agrawal warned that while clinical science is accelerating, trial operations aren’t keeping pace. He outlined a vision for 2035 built on scaling AI, expanding site ecosystems, and bringing trials closer to everyday patient care.

  5. What Can We Expect From The FDA In 2026? 10/20/2025

    Expert panelists at the 2025 RAPS Convergence discussed what lies ahead for the FDA in 2026.

  6. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

    Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

  7. What Is Disease Progression Modeling, And When Is The Right Time To Use It? 10/16/2025

    With the help of Clinical Trials Transformation Initiative's Lindsay Kehoe, discover how disease progression modeling can improve trial efficiency, inform precision medicine, assist in regulatory decision-making, and more.

  8. Diverse Enrollment — Ahem, "Biological Variability" — Gets Widespread Support At RAPS Convergence 10/16/2025

    DEI, diverse enrollment, biological variability -- whatever you call it, industry leaders at RAPS Convergence discussed their unwavering support of it when it comes to executing clinical trials that align "good science" with "the right thing to do."

  9. Trends In Rare Disease Trials: Evaluating Trial Types' Pros, Cons, And Adoption Rates 10/14/2025

    In the second article of the series, Beroe Inc. Lead Analyst Sapna Rani provides a comprehensive evaluation of leading trial types for rare disease development and compares adoption rates, design-specific trade-offs, and practical selection criteria.

  10. Trends In Rare Disease Trials: Trial Designs, Challenges, And Regulatory Progress 10/13/2025

    Beroe Inc. Lead Analyst Sapna Rani unpacks the evolution of trial design types in rare disease research, analyzes ongoing challenges, and examines how regulatory support is enabling innovation in part one of this three-part series.