Regulatory Guidance And Enabling Compliance

  1. Successful Microbial Testing And Identification 5/27/2025

    In this presentation, one of our industry-leading customers discusses how they've successfully implemented the Applied Biosystems MicroSEQ Microbial Identification System in their laboratory testing.

  2. Race To The Regulatory Finish Line: Dr. Nicole Verdun Talks Efficiencies In Platform Technologies 1/30/2024

    Could a platform approach help certain therapies make their way over the regulatory finish line more efficiently?

  3. How The New Administration Could Shape FDA Oversight, Compliance, And Guidance In 2025 4/8/2025

    Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Medicine, and Chief Regulatory Officer of International Society for Cell & Gene Therapy (ISCT) share why the new administration may influence the regulatory landscape for cell and gene therapy, particularly regarding enforcement actions against unproven stem cell products and challenges to FDA authority at the state level.