Regulatory Affairs Editorial

  1. New FDA Program Adds Flexibility For Ultra-Rare Disease Submissions 9/23/2025

    Life science legal experts Mark A. Tobolowsky and Frank J. Sasinowski discuss the FDA's new Rare Disease Evidence Principles (RDEP) initiative.

  2. Gottlieb Warns Leaner FDA Will Challenge ClinOps 9/19/2025

    Former FDA commissioner Scott Gottlieb told DPHARM attendees the agency is strained by staff losses and slowing policy work—leaving ClinOps teams facing tougher reviews, longer waits, and more uncertainty ahead.

  3. FDA Issues New Guidance For Clinical Trial Dosage Of Oncology Therapeutic Radiopharmaceuticals 9/17/2025

    The FDA has issued a draft guidance titled Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development and is accepting public comments through October 20, 2025.

  4. RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It? 9/16/2025

    The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.

  5. How Brazil's New Law Is Redefining The Country's Clinical Research 9/15/2025

    Brazil aims to revamp its clinical research industry with the introduction of a new law intended to make trials faster, empower local ethics committees, and give patients greater post-trial access to investigational drugs.

  6. The New FDA Era Of Radical Transparency And Pervasive Oversight 9/9/2025

    The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.

  7. How Digital Twins Are Rewriting Clinical Trials 9/2/2025

    While the benefits of digital twins to accelerate clinical trials are undeniable, many questions about their use are still unanswered and go far beyond technology.

  8. Insuring Global Clinical Trials: Navigating Risks Across Borders 8/28/2025

    Foreign clinical trials insurance is indispensable. Learn its features, its benefits, and why it's needed.

  9. Where The FDA And EMA Stand On Digital Endpoints 8/22/2025

    In part two of this series on digital endpoints, consultant Anita Burrell reviews the extent of their regulatory acceptance and discusses how to ensure data produced from digital technologies satisfies regulators.

  10. FDA's Elsa May Prompt Pharma To Rethink Regulatory Filings 8/13/2025

    AI expert Pradeepta Mishra of Beghou Consulting explains why pharmaceutical companies need to quickly evolve their regulatory strategies, authoring procedures, and governance frameworks in light of the FDA's new Elsa generative AI pilot.