Regulatory Affairs Editorial

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. FDA Under Pressure To Respond To China-Related Clinical Trials Questions 8/27/2024

    The FDA has until October 1, 2024 to respond to a number of questions regarding concerns about clinical trials being conducted in The People's Republic of China. How will their answers affect trials going forward and the sponsors that were conducting those China-based trials?

  6. Summing Up The FDA's Long-Anticipated Draft Guidance On Diversity Action Plans 8/26/2024

    Life sciences attorney Marylana Saadeh Helou summarizes the FDA's draft guidance on Diversity Action Plans (DAPs).

  7. Individual Participant Data Return Solutions And Strategies 8/22/2024

    Paula Boyles, external clinical trial data-sharing program lead for Pfizer and TransCelerate BioPharma member, shares the benefits of and strategies for individual patient data return (iPDR).

  8. Operationalizing A Diversity Action Plan That Makes An Impact 8/19/2024

    In part two of this series on creating a diversity action plan (DAP), Elevate Advocacy's Devra Densmore shares a detailed plan for creating a DAP that meets FDA expectations.

  9. Diversity Action Plan (DAP): Creating An Ecosystem For Success 8/12/2024

    In part one of this two-part series, Elevate Advocacy Founder Devra Densmore explores how to create an ecosystem in which a successful diversity action plan (DAP) can be written and executed.

  10. FDA Talks Help Cybin Advance Two Psychedelic Drugs Toward Approval 7/26/2024

    Cybin CEO Doug Drysdale discusses regulatory considerations relating to the pursuit of two different psychedelic drugs and talks about trends in the larger psychedelic drug space.