Regulatory Affairs Editorial

41. Decentralized Clinical Trials: Embracing The FDA's 2024 Final Guidance 4/16/2025

    In Sept. 2024, the FDA unveiled a final guidance aimed at advancing decentralized clinical trials. This article shares a summary, describes the differences from the 2023 draft guidance, and provides helpful insight for sponsors.

42. From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials 4/14/2025

    Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.

43. How HHS Budget Cuts And Vaccine Hesitancy Threaten Clinical Trial Operations — And What Leaders Can Do 4/10/2025

    Prof. Stacey B. Lee, Ph.D., examines how the recent Department of Health and Human Services (HHS) staffing cuts and vaccine hesitancy combine to make clinical research much more challenging.

44. What Happens If The National Cancer Institute Loses Funding? 4/3/2025

    The National Cancer Institute is operating under a continuing resolution that maintains funding at the FY 2024 level of $7.22 billion. But when adjusted for inflation, it effectively reduces the real value of research dollars. So what are the consequences?

45. 3 Generative AI Prompts To Strengthen Your SOPs Without Sacrificing Compliance 4/1/2025

    Discover three easy and customizable prompts to help support SOP development, refinement, and training — all areas where AI can add immediate value with minimal downside. 

46. Navigating The 2025 Medtech Regulatory Landscape In Switzerland And The U.K. 3/26/2025

    Switzerland is working toward reestablishing its relationship with the EU while exploring new avenues. Meanwhile, the U.K. is still rebuilding its regulatory framework post-Brexit.

47. As FDA's "Sex Differences" Guidance Reemerges, UCB Reaffirms Importance Of Including Women In Clinical Research 3/26/2025

    UCB Biopharma's Marie Teil explores reasons to prioritize women's inclusion in research and how FDA guidance is poised to support that endeavor.

48. Solving The Protocol Deviation Puzzle With FDA Draft Guidance 3/14/2025

    Knowing exactly what to do when a protocol deviation (PD) arises can be challenging. Here, consultant Leila Cupersmith summarizes new FDA guidance on managing PDs.

49. Takeda's Diversity Strategy Pays Off For Phase 3 Trial 3/12/2025

    LaShell Robinson, head of global feasibility and trial equity at Takeda explains how the company’s Phase 3 trial for a psoriasis drug ended enrollment well before it’s goal and achieved some impressive diversity metrics. 

50. Trends In FDA FY 2024 Inspection-Based Warning Letters 3/7/2025

    Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.