Regulatory Affairs Editorial

  1. 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.

  2. 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.

  3. 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.

  4. Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge 5/29/2026
  5. 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.

  6. 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.

  7. Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials 5/26/2026

    BioAegis Therapeutics CEO Susan Levinson, Ph.D., talks about the role of partner and regulatory support in bringing their investigational immunotherapy into the clinic.

  8. FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors 5/26/2026

    Discover five critical risks created by HALO's architecture and Elsa 4.0's expanded capabilities. Then, learn how to implement practical safeguards sponsors to implement immediately.

  9. FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control 5/22/2026

    ADRES Bio's Rivka Zaibel walks sponsors through the proper response to an FDA Form 483, emphasizing the need to show understanding and control of the situation.

  10. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

    FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.