Regulatory Affairs Editorial

  1. What's Clinical Liability Insurance, And How Does It Work? 8/5/2025

    Life science insurance specialist Kristin Beaulieu explains why sponsors must develop a strategy for scaling their product liability insurance program, detailing two main product liability types to consider.

  2. 5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution 7/29/2025

    Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.

  3. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

    ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.

  4. All Of Us Need To Be Rooting For The FDA 7/23/2025

    In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.

  5. What Sponsors Must Know About Digital Systems And AI Compliance 7/17/2025

    Consultant Jessica Cordes provides an update on proposed changes to GMP guidance that affect trial conduct, including documentation, computerized systems, and the use of AI.

  6. How To Avoid Hazards And Map A Safer, Smarter Path For AI, Part 2 7/15/2025

    The AI journey is full of hidden potholes, unexpected detours, and costly wrong turns. In part two of this series, Tanisha Patel and Vincent Puglia explore more considerations for integrating AI in clinical research.

  7. How To Avoid Hazards And Map A Safer, Smarter Path For AI, Part 1 7/15/2025

    Even with a clear destination with real rewards, the AI journey is full of hidden potholes, unexpected detours, and costly wrong turns. Tanisha Patel and Vincent Puglia explore several considerations when integrating AI in clinical research.

  8. A Guide To Guidelines: How ICH And Others Help Us Conduct Better Trials 7/11/2025

    Guidelines abound in clinical research. So, how should sponsor companies and partners think about their role in ensuring compliance? Consultant Kamila Novak explores their importance.

  9. How An Australia-First Strategy Cut 63% From Our R&D Spend 7/10/2025

    Etira CEO Russell Hayward explains how conducting the company's early-stage trials in Australia has yielded big savings, shortened timelines, and produced FDA-ready data.

  10. Population-Aware Medicine: Mitigating Racial Disparities In Efficacy And Accuracy 6/26/2025

    Medicine is not one-size-fits-all. Here, strategic advisor Bill Hanlon implores pharma to develop therapeutics and diagnostics anchored by racial and ethnic diversity.