Regulatory Insights

  1. Analytics–Powered Approach To Patient Recruitment Strategy 7/15/2025

    In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.

  2. Off-Script FDA: How Smart Teams Pivot, Escalate, And Progress 7/15/2025

    Dr. Rachel Sherman, former Principal Deputy Commissioner of the FDA, explains the rules of engagement for working with today’s FDA.

  3. Controlling Comment Chaos: A Medical Writing Leader's Story 7/14/2025

    Discover how Sarah Wilson, Director at Alkermes, revolutionized document collaboration using a document review platform to boost efficiency and overcome regulatory challenges in medical writing.

  4. Strategies For QA Professionals In Life Sciences 7/14/2025

    Explore challenges QA professionals face in document reviews and expert strategies to boost accuracy, streamline workflows, and ensure compliance with evolving regulatory standards.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.