Regulatory Insights

  1. Advancing Drug Safety: The Synergy Of Regulatory Affairs And Pharmacovigilance 7/14/2025

    Explore how pharmacovigilance and regulatory affairs teams work together throughout a product's lifecycle to monitor risks and keep vital safety information updated.

  2. The New Language Of E6 R3: What Makes The Guidelines So Different? 7/14/2025

    Unpack the significant changes in ICH E6 (R3), nearly a decade after its last update. This revision brings renewed focus to quality by design and digital provenance.

  3. 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.

  4. 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.

  5. FDA Expands Unannounced Foreign Manufacturing Inspections 7/9/2025

    Unannounced FDA inspections are now the norm for foreign manufacturers. Learn how this pivotal shift impacts global drug, biologic, and device companies and how to prepare.

  6. Key Takeaways From The PDA Ireland Good Distribution Practice Event 7/9/2025

    Gain valuable takeaways from the PDA Ireland GDP event, covering essential insights on supply chain challenges, regulatory expectations, and the role of future technologies in pharmaceutical distribution.

  7. Advancing Sterile Manufacturing: A Strategic Imperative For Modern Pharmaceutical Production 7/9/2025

    Ensuring sterile drug production is vital for patient health and a key regulatory focus. Discover core principles and emerging trends in sterile manufacturing.

  8. 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.

  9. 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.

  10. 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.