Regulatory Insights

  1. The Makings Of 'Regulatory-Grade' Real-World Data In Ophthalmology Using AI 5/20/2025

    Regulatory bodies like the FDA and EMA now prioritize real-world data in clinical research. Learn more about its value in enhancing drug development, regulatory decisions, and patient outcomes.

  2. How AI Is Shaping The Creation Of 'Regulatory-Grade' Real-World Data 5/20/2025

    Regulatory agencies such as the U.S. FDA and the EMA are increasingly recognizing the value of real-world data (RWD) in shaping clinical research and informing regulatory decisions.

  3. Balancing Science With Intellectual Property 5/16/2025

    Joshua Kresh, Emily Michiko Morris, and Mark Schultz from IPPI: The Intellectual Property (IP) Policy Institute discuss the dos and don’ts of IP and trade secrecy protections for biotech.

  4. Why ePROs In Oncology Are Perfect For Capturing The Patient's Voice 5/15/2025

    Late last year, the FDA issued new guidance showcasing why electronic patient reported outcomes are ideal at capturing the “voice” of the patient. See what the FDA expects, and why ePRO eases oncology trials, with this blog.

  5. The Role Of FDA Initiatives In Early-Phase Oncology Trials 5/15/2025

    Project FrontRunner represents a paradigm shift in oncology drug development, championing earlier-line studies to bring novel treatments to patients sooner.

  6. Why Biotech Leaders Can't Afford Delays In Document Review 5/15/2025

    Document review is a hidden bottleneck in biopharma. Learn how inefficiencies in this critical process can delay drug development and what you can do to accelerate time to market.

  7. Infectious Diseases - Global Clinical Trial Landscape (2025) 5/14/2025

    The global infectious disease clinical trial landscape has rapidly expanded between 2020 and 2024, driven by the urgency of emerging threats, technological innovation, and evolving regulatory frameworks.

  8. Europe Has A Platform For Driving More Flexible Clinical Trials: It's Time To Use It 5/13/2025

    Despite recent setbacks, Europe possesses inherent strengths in clinical research, and a concerted effort is needed to transform its potential into a thriving and competitive environment.

  9. Regulatory Opportunities For Decentralized Clinical Trials: Insights From The SHASTA Project 5/13/2025

    Project SHASTA, a pioneering effort to measure the benefits of decentralized trial elements, reveals significant regulatory opportunities that could shape the future of clinical research.

  10. Developing Drugs For Rare Diseases: A New Approach To Generating Clinical Evidence 5/13/2025

    For rare diseases, scientific breakthroughs often stall before reaching patients. A new approach to generating clinical evidence could change that trajectory.