Regulatory Affairs Editorial

  1. How Government Shutdowns Set Back Clinical Trials 10/3/2025

    When the federal government shuts down, clinical research suffers. Empactful Ventures' Denise N. Bronner, Ph.D., explains the wide-reaching ramifications.

  2. FDA Pharma Advertising Crackdown Reshapes Clinical Research, Too 10/1/2025

    Empactul Ventures' Denise N. Bronner, Ph.D., explores how the FDA's crackdown on pharmaceutical advertising might affect clinical research patient recruitment and engagement.

  3. GCP Oversight Simplified: A Quick Guide 9/29/2025

    Discover practical, real-world strategies for sponsors to operationalize GCP oversight in a way that is collaborative, measurable, and scalable.

  4. Site-Level Change Model And Successful Strategies For Medicare Compliance In Clinical Trials 9/26/2025

    Discover best practices for achieving and maintaining Medicare billing compliance for clinical trials.

  5. What The FDA Says About Investigator Responsibilities In DCTs 9/25/2025

    Learn exactly what the FDA says about the use of healthcare providers (HCPs), telemedicine, licensing, and practice standard requirements when executing a DCT.

  6. When "Imperfect" AI Models Still Add Value In Pharma Quality 9/24/2025

    AI isn't perfect, and that's OK, says ERA Science's Andy O'Connor. Here, he contends that if we can prove and explain how a human+AI process outperforms a human-only process, then imperfection is still progress.

  7. 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.

  8. 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.

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    The FDA has issued a draft guidance titled Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development and is accepting public comments through October 20, 2025.

  10. 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.