Regulatory Affairs Editorial

31. 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.

32. 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.

33. 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.

34. 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.

35. 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."

36. 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.

37. 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.

38. How Enveric Biosciences Is Prepping For Its First IND 10/10/2025

    Enveric Biosciences CEO Joseph Tucker, Ph.D., discusses how the team is finalizing IND-enabling studies, leveraging both in-house expertise and trusted external partners.

39. Post-Trial Access: Compliance Lessons Hidden In Plain Sight 10/8/2025

    What happens when the trial ends and the investigational product is no longer available? Edye T. Edens, JD, MA, CIP, CCRP, talks through the answer.

40. SCDM 2025: Practical Advice From Global Regulators — Including The FDA 10/6/2025

    Discover what regulators from around the world, including the FDA, think should be top of mind for clinical data managers.