Regulatory Affairs Editorial

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. The Effects Of Most Favored Nation Drug Pricing On Clinical Trial Management 6/24/2025

    Market expert Mathini Ilancheran explains how sponsors can mitigate the effects of "Most Favored Nation" drug pricing while maintaining trial integrity and accelerating time to market.

  8. Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight 6/23/2025

    Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

  9. Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs 6/20/2025

    The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.

  10. How Is RIM Software Transforming Regulatory Compliance? 6/20/2025

    Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.