Prevent A Clinical Trial From Turning Into A Criminal Trial – Healthcare – United States – Mondaq




On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” during the Food and Drug Law Institute's Clinical Trials: Deconstructing Challenges and Providing Practical Insights Conference. The panel featured a high-ranking attorney from the Department of Justice's (DOJ) Consumer Protection Branch (CPB) and other regulatory compliance leaders to discuss key trends and issues in clinical trial enforcement that underscored the need to ensure appropriate compliance measures are in place to avoid future investigations.
Key takeaways regarding the trajectory of clinical trial fraud investigations and enforcement actions include:
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Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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