Regulatory Affairs Editorial

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

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 Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs 6/20/2025

    The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.

  7. 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.

  8. Why CRA Proficiency Needs A Boost From Better Assessment And Training 6/20/2025

    CRAs intend to fulfill clinical research’s commitment to patient safety. Yet, some fall short of true proficiency, and Gerald DeWolfe contends better evaluations and training can help.

  9. EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence? 6/19/2025

    The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

  10. 25 Tips To Prepare A Clinical Site For FDA Inspection 6/17/2025

    During the last year I have interviewed six former FDA investigators and a regulatory expert who has been involved with more than 250 inspections. From all those interviews, I’ve culled the following list of takeaways that I hope you will find useful when preparing for any type of regulatory inspection.