Regulatory Affairs Editorial

  1. How PDS Biotech Approached FDA Meetings For Its Phase 3 Cancer Trial 2/11/2025

    PDS Biotech CMO Kirk Shepard reveals his team’s interactions with the FDA as it sought to begin its Phase 3 trial for the treatment of HPV-positive recurrent and/or metastatic head and neck squamous cell carcinoma.

  2. FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program 2/10/2025

    The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.

  3. Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars 2/10/2025

    With an projected global market value of $35.7 billion in 2025, biosimilars are slated for considerable growth opportunities, thanks in part to clinical regulatory changes.

  4. Input Needed On Using AI To Create Lay Summaries Of Trial Results 2/7/2025

    CISCRP is soliciting feedback from research professionals, patients, and advocacy groups on its "Considerations for Using AI to Create Lay Summaries of Trial Results" until Feb. 18.

  5. FDA Issues Draft Guidance: Study Of Sex Differences In The Clinical Evaluation Of Medical Products 1/29/2025

    The U.S. FDA's recent draft guidance on the Study of Sex Differences in the Clinical Evaluation of Medical Products deduces that individuals whose sex is assigned as “female” at birth are underrepresented in clinical trials. The public comment period ends April 7 (in theory), though it should be noted that the guidance was removed from the FDA website shortly after the new administration took office.

  6. Biopharma R&D Faces Productivity And Attrition Challenges In 2025 1/29/2025

    Evaluate VP of Thought Leadership Daniel Chancellor discusses trends for 2025 as the surge in R&D, coupled with rapidly evolving industry dynamics, presents a productivity and attrition challenge for the industry.

  7. FDA Provides Updated Draft Guidance To Support E6(R3) 1/27/2025

    Get a quick but thorough understanding of the latest guidance updates with this summary of "E6(R3) Good Clinical Practice: Annex 2."

  8. Should We Still Be Using Trackers For Clinical Trial Management? 1/23/2025

    While excitement abounds for AI in clinical research, many professionals are still using manual trackers and logs to record data related to monitoring visits, protocol deviations, and more. TMF consultant Donatella Ballerini discusses the relevancy of tracks and logs today.

  9. What Future Laboratory Manuals Should Look Like 12/20/2024

    In the final article of this series on lab manuals, FlexPoint Bio Founder and CEO Elena Sinclair imagines what the perfect lab manual might look like — and how to make it a reality.

  10. Lab Manual Gaps: Sabotaging Data One Sample At A Time 12/19/2024

    In part two of this series on lab manuals, FlexPoint Bio Founder and CEO Elena Sinclair discusses the criticality of sample and process quality.