Regulatory Affairs Editorial

41. 3 Strategies For A Successful Journey Toward Cell And Gene Therapy Commercialization 5/13/2025

    CTMC's Amy Hay provides 3 recommendations for teams developing cell and gene therapies, from clinical research through commercialization.

42. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 2 5/13/2025

    This article focuses on the common regulatory threads that connect different regions and the global standards and principles being developed to bring consistency, safety, and trust to AI innovation in medical devices.

43. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

    Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

44. U.K. Has Strong Plan To Reform Clinical Trials 5/8/2025

    The U.K.’s 2025 clinical trial reforms aim to boost research efficiency, inclusivity, and global competitiveness by streamlining approvals, enhancing patient involvement, and addressing structural, demographic, and therapeutic gaps in trial activity.

45. How Close Is The First FDA-Approved Full-Spectrum Botanical Drug For Autism? 5/6/2025

    AJNA BioSciences CEO Joel Stanley details his transition from helping to build one of the largest CBD companies to developing what he hopes will become an FDA-approved botanical drug to treat the symptoms of autism.

46. EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval 5/5/2025

    In April, the European Medicines Agency issued a draft of a new guidance document titled Reflection paper on a tailored clinical approach in biosimilar development. The public consultation runs until Sept. 30, 2025.

47. DEI Was Never the Problem, The Way Pharma Did It Was 5/5/2025

    Consultant Denise Bronner details pharma's strategic rollback of DEI initiatives, roles, and even departments and explains why well-meaning but misguided intentions enabled their demise.

48. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1 5/1/2025

    This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. 

49. The Evolving Landscape Of Data Integrity In Good Clinical Practice 4/30/2025

    ERA Sciences Andy O'Connor explores the growing focus on data integrity in good clinical practice (GCP) and how regulatory guidance is evolving to support a risk-based, system-life cycle approach.

50. Sponsor Oversight Strikes Back: Outsourcing Everything But The Responsibility Under ICH E6 (R3) 4/28/2025

    If E6 (R3) is ushering in the era of Quality by Design, clinical development consultant Angus Henderson says it's time we talk seriously about oversight by design.