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# Takeaways from Clinical Trial Enforcement Panel
- URL: https://www.fdaweb.com/takeaways-from-clinical-trial-enforcement-panel/
- Published: 2022-11-16T12:00:00.000Z
- Updated: 2026-09-14T18:06:40.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5153210

Four Morrison Foerster attorneys say a panel on “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement” held on 11/2 at a Food and Drug Law Institute conference featured a high-ranking attorney from the Department of Justice consumer protection branch and other regulatory compliance leaders to discuss key trends and issues in clinical trial enforcement. In an online [post](https://lifesciences.mofo.com/topics/prevent-a-clinical-trial-from-turning-into-a-criminal-trial?ref=fdaweb.com), they list these takeaways:

- confirmation that the Justice Department is looking not only at the activities of individuals, but also big corporate actors with a specific focus on the submission of false and misleading data to FDA and obstruction of FDA and other regulators;
- pursuing cases under the Federal Food, Drug, and Cosmetic Act, including felony or misdemeanor criminal actions;
- FDA inspection classification does not determine whether the Justice Department will bring an action;
- special attention to cybersecurity and digital enrollment; and
- steps sponsors and other corporate actors can take to mitigate department enforcement risk.