Regulatory Affairs Editorial

  1. An FDA First: Dompé Shares Experience Of Securing A Commissioner's National Priority Voucher 11/25/2025

    Dompé Chief Development Officer Ahmed Enayetallah reveals how the team earned the FDA's new Commissioner’s National Priority Voucher.

  2. LinkedIn Message Leads To Advocate-Pharma Pursuit Of Expanded Access 11/21/2025

    Medicus Pharma CEO Raza Bokhari, MD and Gorlin Syndrome Alliance Executive Director Meredith Weiss describe how the two a partnering to match Medicus’ noninvasive treatment for basal cell carcinoma with GSA’s patient community.

  3. 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    The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products.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.

  4. 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. 

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.