Featured Insights

  1. 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.

  2. 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.

  3. 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.

  4. HTA In Japan: The Glass Remains Half Full (For Now) 6/12/2025

    While Japan's current HTA system is seen as pro-innovation, potential reforms in 2026 could expand its scope, creating uncertainty for manufacturers in one of the world's largest markets.

  5. Early Access Program In France: How Much Of An Opportunity Is It? 6/12/2025

    Navigating France’s Early Access Program is more complex than ever. Amid declining approval rates and mandatory data collection, here’s what pharmaceutical companies need to know about the changing landscape.

  6. Insights From Pharma 2025: The Impact Of The European Health Data Space (EHDS) Reform On Healthcare Systems 6/12/2025

    Experts explore the revolutionary European Health Data Space, a reform designed to enhance patient data control, streamline care across borders, and unlock new opportunities for medical research.

  7. Insights From Pharma 2025: The Role Of Patient Journey 6/12/2025

    From predictive AI to the European Health Data Space, experts discuss how digital transformation is reshaping patient care, creating new pathways for commercial success in pharmaceuticals.

  8. Insights From Pharma 2025: Elevating Patient Engagement 6/12/2025

    A significant gap exists between drug development and patient use. Industry veteran Mark Duman explains why listening to patients is the key to closing it and improving health outcomes.

  9. Insights From Pharma 2025: Leadership In Pharma – Empowering Change Through Innovative Thinking 6/12/2025

    What does it take to lead in today's evolving pharmaceutical landscape? Insights from Pharma 2025 reveal that empowering teams through trust, experimentation, and a shared purpose is key.

  10. Inclusion Of Health-Related Quality Of Life (HRQoL) And Other Patient-Reported Outcomes (PROs) In FDA Labels 6/12/2025

    With a growing emphasis on patient-centric drug development, new research examines how frequently patient-reported outcomes are actually making it onto United States Food and Drug Administration labels.