Regulatory Affairs Editorial

  1. PI Insights From A Heart Failure Trial: Part 1 11/14/2024

    Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF clinical trial, talks about her role as a PI including trial design and meetings with the FDA.

  2. FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission 10/18/2024

    The FDA has issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1. This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit.

  3. The Regulatory Affairs Function Is Evolving. Are You Evolving With It? 10/10/2024

    The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.

  4. How One Biotech Is Using FDA 505(b)(2) To Get Drugs To Patients Quicker And Cheaper 10/9/2024

    Terran Biosciences CEO Sam Clark, MD, Ph.D. explains how his team is leveraging the 505(b)(2) regulatory pathway to get its new schizophrenia drug to patients quickly and affordably. 

  5. An Expert Guide To Effective Sponsor Oversight In Clinical Trials 10/8/2024

    Consultant Jessica Cordes explains how combining thorough sponsor oversight with robust risk management practices, sponsors can significantly enhance the quality and reliability of clinical trials. 

  6. The Crucial Role Of Sponsor Oversight In ICH E6 (R3) 10/7/2024

    ADRES Bio leaders Inbal Hacmon and Rivka Zaibel delve into the critical aspects of ICH E6 (R3), shedding light on its implications for clinical trial sponsor responsibilities.

  7. Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide 10/4/2024

    ISPE GAMP Guide lead author Frank Henrichmann describes the changing clinical data environment and details updates that will support the work of various clinical trial stakeholders. 

  8. Continuing Rare Disease Treatment With A Compassionate Use Program (CUP) 10/2/2024

    Learn how Rezolute successfully led its investigational drug for treating congenital hyperinsulinism (cHI) through a compassionate use program.

  9. Compassionate Use Program (CUP) Benefits & Strategies In Rare Disease 10/2/2024

    In part two of this series, Rezolute discusses the benefits of continuing patient care with a compassionate use program (CUP) and shares best practices for implementing one.

  10. Research, Manufacturing, Regulatory, And More: What Are The Challenges With CGTs? 9/27/2024

    UCB Head of U.S. Research Roger Palframan discusses the challenges with CGTs — from complex manufacturing to the need for greater and more meaningful patient engagement to evolving regulations and reimbursement.