Regulatory Affairs Editorial

  1. 5 Informed Consent Fixes For Sponsors And Investigators 7/14/2026

    Informed consent has never been solely about documentation, but some sponsors has treated it as a checkbox exercise. Here, consultant Tasha Mohseni shares tips and fixs for how best to approach informed consent.

  2. Navigating The New EU Pharmaceutical Legislation: Key Implications For Pediatric Drug Development 7/13/2026

    UCB’s Senior Development Strategy Lead Pediatrics Martine Dehlinger-Kremer, Ph.D., discusses updates to the new EU Pharma legislation and how they impact pediatric drug development, including earlier pediatric investigational plans .

  3. Beyond The IND Clock: What Operation TrialBlazer Gets Right — And Where It Stalls (Part 1) 7/10/2026

    The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But will it work? Kimberly Chew and Odette Hauke identify where the initiative succeeds and where the structural gaps begin.

  4. Beyond The IND Clock: The Legal Architecture Of QRIs And What Industry Must Say Before July 22 (Part 2) 7/10/2026

    The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But Kimberly Chew and Odette Hauke say its legal architecture is unresolved and reveals compliance issues that are hard to ignore.

  5. Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDA 6/17/2026

    For nonprofit organizations, Orphan Drug Designation is the start of a disciplined, forward-looking regulatory strategy, but it's not the only factor in success. H. Greg Thomas, Ph.D., shares his advice for de-risking orphan drug development.

  6. What It's Like To Advance A Cell Therapy Through The Japan Entry Acceleration Program 6/15/2026

    Ernexa Therapeutics President & CEO Sanjeev Luther details having one the of 10 coveted spots in the Japan Entry Acceleration Program (JEAP) that supports cell therapy development and market entry in Japan.

  7. New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA 6/9/2026

    NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.

  8. The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn't It? 6/8/2026

    Strep A kills around 500,000 people each year, and a vaccine would change this and is within reach. Yet, no strep A vaccine is currently in Phase 3. 1Day Sooner's Josh Morrison explains why and shares how FDA could make Strep A vaccines a reality.

  9. 3 Views From Inside FDA's RTCT Pilot 6/5/2026

    The FDA's RTCT pilot promises to bring clinical trials into the real-time era, but questions remain about governance, oversight, and implementation. We asked three organizations participating in the initiative what they see as the opportunities, challenges, and realities behind the FDA's most ambitious modernization effort in years.

  10. What Is Computer Software Assurance, And What Are Its Benefits? 6/2/2026

    Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.