Regulatory Insights

31. Writing Effective Clinical Regulatory Documents For Therapy Trials 7/11/2025

    Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. Navigating Regulatory Uncertainty: Diversity Action Plans 7/8/2025

    Sponsors planning Phase 3 and pivotal clinical trials are facing fresh uncertainty as the FDA’s Diversity Action Plan guidance continues to shift.

38. Mitigating Risk With Ex-U.S. 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.

39. 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.

40. 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.