Regulatory Insights

  1. Transforming Medicine: Strategies In CAGT Development 2/17/2025

    As cell and gene therapies (CAGTs) evolve, adaptive strategies are crucial to accelerating development and ensuring timely patient access.

  2. Pioneering Strategies For Early Phase Oncology Trials 2/17/2025

    As the field advances, adaptive methodologies and regulatory shifts redefine early-phase oncology trials, promoting efficiency, flexibility, and equitable access.

  3. Understanding The New FDA Guidance On Decentralized Clinical Trials 2/11/2025

    Explore the evolution of the FDA decentralized clinical trial (DCT) guidance, highlighting key updates on responsibilities, data variability, inspections, and trial design.

  4. Legal Changes To Fortify Environmental Risk Assessment Of Pharmaceuticals 2/3/2025

    A new EU directive may require stricter environmental risk assessments for pharmaceuticals, impacting marketing authorization. Updated guidelines already in effect pose new challenges for companies.

  5. The Digital Pharmaceutical Journey: 2025 And Beyond 2/3/2025

    By 2025 and beyond, AI, structured data, and real-world evidence will reshape the landscape, driving personalized medicine and more efficient processes. Here are eight key trends to watch.

  6. Topic Sterility Assurance With Noelle Clifford 2/3/2025

    Sterility assurance requires robust programs from raw materials to facility design. Learn about best practices, misconceptions, and the importance of environmental monitoring and regulatory compliance.

  7. Analyzing The FDA's Approach To Diversity In Clinical Trials 1/31/2025

    Learn how utilizing diverse data resources and collaborating with stakeholders enables sponsors to foster a culture of inclusivity, meet regulatory requirements and ultimately advance medical science.

  8. The FDA's Remote Regulatory Assessments: The Future Of Inspections 1/31/2025

    Remote Regulatory Assessments (RRAs) provide distinct advantages over traditional inspections, such as increased efficiency, reduced travel costs, and enhanced global oversight capabilities.

  9. What Is Healthcare Data Interoperability And Why Does It Matter For Clinical Research? 1/28/2025

    Explore how healthcare data interoperability can transform patient outcomes, streamline clinical research, and enhance efficiencies while addressing key challenges and global initiatives.

  10. Understanding The FDA's Push For More Representation In Clinical Trials 1/28/2025

    Take action to improve diversity in clinical trials by addressing underrepresentation and ensuring equitable access to medical interventions, as emphasized by the FDA’s new 2025 guidance.