Regulatory Affairs Editorial
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Trends In Rare Disease Trials: Evaluating Trial Types' Pros, Cons, And Adoption Rates
10/14/2025
In the second article of the series, Beroe Inc. Lead Analyst Sapna Rani provides a comprehensive evaluation of leading trial types for rare disease development and compares adoption rates, design-specific trade-offs, and practical selection criteria.
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Trends In Rare Disease Trials: Trial Designs, Challenges, And Regulatory Progress
10/13/2025
Beroe Inc. Lead Analyst Sapan Rani unpacks the evolution of trial design types in rare disease research, analyzes ongoing challenges, and examines how regulatory support is enabling innovation in part one of this three-part series.
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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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.