Regulatory Affairs Editorial

31. 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.

32. 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.

33. Unsure About The New ICH Guidelines? TransCelerate Debuts 13 Tools To Help 4/23/2025

    TransCelerate BioPharma's Tashan Mistree discusses 13 new tools created alongside the Association of Clinical Research Organizations (ACRO) to support ICH GCP E6(R3) adoption.

34. Racial Inequities In Medicine: The Consequences Of Historical Unethical Experimentation In Clinical Trials 4/22/2025

    In part two of this series on racial inequities in clinical research, the authors discuss the impact those trials have had on clinical research in the Black community, especially for women.

35. Racial Inequities In Medicine: The History Of Unethical Race-Based Experimentation 4/21/2025

    Unethical and even brutal clinical research of the 19th and 20th centuries targeted the Black community. Discover how the medical mistreatment of Black patients and participants shaped how the community sees trials today.

36. 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 This article shares a summary, describes the differences from the 2023 draft guidance, and provides helpful insight for sponsors.

37. 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.

38. 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.

39. 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?

40. 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.