Regulatory Affairs Editorial

31. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

    The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

32. Why Perfect Clinical Trial Data Is A Dangerous Myth 6/2/2025

    Former FDA inspector Kara Harrison reveals clinical trials fail due to overcomplex designs, checklist-driven monitoring that misses critical issues, and lack of focus on what actually matters for patient safety and data integrity.

33. Here's Your 483 — And Your Hug 5/27/2025

    Former FDA inspector Tracey Harris shares what clinical sites get right, what they botch completely, and why inspection readiness is about more than coffee, binders, or bluffing.

34. Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services 5/22/2025

    The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

35. Spiders, Mold, & SOPs: Tales From A Site Inspection Veteran 5/22/2025

    Sarah Moeller, a veteran of mock regulatory inspections, shares lessons from over 300 site visits, emphasizing preparation, documentation, and patient-focused practices to ensure sites are inspection-ready.

36. What's The Risk Of Letting Researchers Use LLMs? 5/21/2025

    Who should be using AI and how? Sage Therapeutics' Jake Alme explores AI use in clinical research, examining its use shifting toward more complex applications and discussing the risk of using it in the public domain.

37. Celebrating Clinical Trials Day, Part 2: Trial Optimization In Action 5/20/2025

    Celebrate Clinical Trials Day 2025 with these industry experts as they share experiences and advice related to trial design, regulatory and compliance, and outsourcing challenges.

38. 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.

39. 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.

40. 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.