Regulatory Affairs Editorial

  1. Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development 11/17/2025

    The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

  2. Non-Invasive Brain-Computer Interface Trial Balances Regulatory Requirements With Patient Needs 11/13/2025

    Cognixion CTO Chris Ullrich introduces the Axon-R Nucleus bio-sensing hub and discusses its feasibility trial, highlighting the importance of patient input, caregiver quality of life, and regulatory support. 

  3. Two Former FDA Chiefs, Two Very Different Warnings 11/6/2025

    Former FDA Commissioners Scott Gottlieb and Robert Califf are sounding alarms from opposite ends of the industry. Gottlieb warns that a leaner, under-resourced FDA will make life harder for clinical operations, while Califf argues the deeper failure lies in a healthcare system that’s forgotten how to learn from itself. Together, they paint a sobering picture of what’s really broken in clinical research — and why fixing it will take more than new guidance.

  4. Global Implications Of Zero Tariffs On Indian Pharma Exports To China 11/5/2025

    Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.

  5. How The U.S. Can Beat China In Biotech 11/3/2025

    Lumen Bioscience's Brian Finrow breaks down China's biotech playbook and explores ways the U.S. can adapt it for its own continued success.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.