Regulatory Affairs Editorial

  1. Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide 10/4/2024

    ISPE GAMP Guide lead author Frank Henrichmann describes the changing clinical data environment and details updates that will support the work of various clinical trial stakeholders. 

  2. Compassionate Use Program (CUP) Benefits & Strategies In Rare Disease 10/2/2024

    In part two of this series, Rezolute discusses the benefits of continuing patient care with a compassionate use program (CUP) and shares best practices for implementing one.

  3. Continuing Rare Disease Treatment With A Compassionate Use Program (CUP) 10/2/2024

    Learn how Rezolute successfully led its investigational drug for treating congenital hyperinsulinism (cHI) through a compassionate use program.

  4. Research, Manufacturing, Regulatory, And More: What Are The Challenges With CGTs? 9/27/2024

    UCB Head of U.S. Research Roger Palframan discusses the challenges with CGTs — from complex manufacturing to the need for greater and more meaningful patient engagement to evolving regulations and reimbursement.

  5. Why Sponsors And Sites Must Prioritize Coverage Analysis In Clinical Trials 9/26/2024

    Huron Consulting Group's Casey Charlton explains why conducting a coverage analysis (CA) is a crucial step in the pre-award workflow for sites participating in clinical trials.

  6. The Value Of A High-Performing Regulatory Function Within A CRO 9/25/2024

    Consultant Pete Embley discusses the value a regulatory expert brings to both CROs and sponsors alike.

  7. Key Takeaways From Clinical Trial Diversity Discussion 9/24/2024

    During the Clinical Leader Live, The Diversity Mandate: Effective Strategies in Clinical Trials”, we discussed everything from the guidance, to diversity action plans, to the need for better data on race, ethnicity, and identity. In this article, we also share 25 questions audience members had regarding this hot topic.

  8. Why Sponsors Must Check For Site GCP Adherence During Feasibility Studies 9/19/2024

    GCP consultant Donatella Ballerini explores how adherence to GCP influences site feasibility, shaping the success and credibility of a clinical trial.

  9. FDA Finalizes Guidance On Dose Optimization For Oncology Therapies 9/16/2024

    The FDA recently finalized its guidance on "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases" — with a few notable updates since its draft.

  10. The Small Biotech's Checklist For FIH Trials 8/27/2024

    Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.