Regulatory Affairs Editorial

  1. How Enveric Biosciences Is Prepping For Its First IND 10/10/2025

    Enveric Biosciences CEO Joseph Tucker, Ph.D., discusses how the team is finalizing IND-enabling studies, leveraging both in-house expertise and trusted external partners.

  2. Post-Trial Access: Compliance Lessons Hidden In Plain Sight 10/8/2025

    What happens when the trial ends and the investigational product is no longer available? Edye T. Edens, JD, MA, CIP, CCRP, talks through the answer.

  3. SCDM 2025: Practical Advice From Global Regulators — Including The FDA 10/6/2025

    Discover what regulators from around the world, including the FDA, think should be top of mind for clinical data managers.

  4. Import Product Specifications And Drug Registration Testing For China 10/6/2025

    This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.