Regulatory Articles

  1. Aligning Standards, Validation, And Governance For Digital Preclinical Research 6/18/2026

    No single body integrates preclinical data components into a coherent discipline supported by shared standards, common terminology, and collective accountability.

  2. FDA's New Oncology Guidance Signals The Next Phase Of Drug Development Reform 6/2/2026

    New FDA guidance encourages streamlined nonclinical safety assessments for certain cancer therapies and explicitly seeks to reduce unnecessary animal testing while maintaining patient safety.

  3. Executive Order For Psychedelics 5/8/2026

    We caught up with Joseph Tucker, Ph.D., CEO of Enveric Biosciences, to discuss the executive order for psychedelics.

  4. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

    Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

  5. FDA's New Flexible CMC Framework For CGT 4/14/2026

    The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

  6. Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic 4/9/2026

    MimiVax CEO Mike Ciesielski recounts the company's transition from academia to industry, hitting on topics like vendor partnerships, FDA conversations, and manufacturer selection. 

  7. NAMs In France And Europe: The Current Landscape 3/20/2026

    The EU is establishing a credible and scalable NAM ecosystem, but challenges still need to be overcome before life sciences professionals and patients can reap the benefits.

  8. Thoughtful Supply Strategy Is No Longer Optional In Drug Development 2/16/2026

    In drug discovery and development, supply chain decisions are often treated as a downstream concern. In reality, supply strategy is a development decision from the very beginning.

  9. New Approach Methods In Practice: Where Are We Today? 2/10/2026

    NAMs have moved beyond a technological promise, but now the current challenge is to operationalize their adoption.

  10. Flow Chemistry For Contemporary Isotope Labeling 1/26/2026

    Gain insight into how late‑stage exchange and flow‑based methods enable efficient access to labeled molecules for pharmaceuticals, mechanistic studies, and analytical applications.