Regulatory Insights

  1. Enhancing Readiness For FDA's Expanded Foreign Inspection Program 7/10/2025

    Learn about the FDA’s expanded, unannounced inspection program for foreign manufacturing sites that aims to align oversight of global pharmaceutical and medical device production with domestic GMP standards.

  2. Understanding The Commissioner's National Priority Voucher 7/10/2025

    The Commissioner's National Priority Voucher (CNPV) reflects the FDA’s focus on modernizing review processes, integrating AI and non-animal models, and bringing treatments to patients faster.

  3. Mitigating Risk With Ex-US Clinical Trials 7/8/2025

    Gain insight into why certain regions offer strategic advantages, from regulatory flexibility to faster enrollment, and how to effectively integrate them into your development strategy.

  4. Accelerating Trial Start-Up: CRO Best Practices For 2025 7/8/2025

    In 2025, accelerating clinical trial start-up is critical, and Clinical Research Organizations (CROs) are applying innovative approaches to drive efficiency in site activation, enrollment, and regulatory approvals.

  5. Live Biotherapeutic Products: Unique Quality, Manufacturing And Nonclinical Considerations For Clinical Trial Entry 7/8/2025

    Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.

  6. CMC Strategies For Cell And Gene Therapy Development 7/2/2025

    The regulatory environment for cell and gene therapies (CGTs) is evolving rapidly, requiring sponsors to adopt a more strategic, integrated development approach.

  7. Project Optimus Explained: Shifting Away From Maximum Tolerated Dose 7/2/2025

    Project Optimus represents a transformative shift in oncology, advocating for a more nuanced, evidence-based approach to dose selection, prioritizing patient safety alongside treatment effectiveness.

  8. Best Practices For Gene Therapy BLA/MAA Submissions 7/1/2025

    Medical writers completing gene therapy submissions require strategic placement, justification, and cross-referencing to fit unconventional data within a standard template.

  9. Expert Guidance For EU Gene Therapy And Companion Diagnostic Trial Regulations 6/27/2025

    This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

  10. Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration 6/26/2025

    A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.