Regulatory Affairs Editorial

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. The FDA Is Rudderless And Clinical Trials Are Left Adrift 6/2/2026

    Former commissioner Marty Makary, MD, left the FDA in May 2026. In his wake, he left an agency facing yet another wave of uncertainty. Denise N. Bronner attempts to navigate the latest change and offers advice for those seeking stability.

  8. Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge 5/29/2026
  9. Clinical Trial Ads, Informed Consent, And Half-Hearted Regulation 5/27/2026

    Should informed consent really start with clinical trials ads? And if not, why do IRBs need to be involved in their approval? Paul Ivisin unravels the tangled web of IRBs, regulators, and clinical trial advertisements.

  10. My View: The Clinical Trials Technology Congress 5/26/2026

    I attended the inaugural Clinical Trials Technology Congress in London expecting to hear plenty about AI, digital tools, and the future of clinical trials. What stood out instead was how many speakers focused on a much more immediate issue: reducing complexity for sites, patients, and study teams.