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:
MoFo's FDA + Healthcare Regulatory and Compliance practice works seamlessly with our Investigations + White Collar Defense, Global Ethics + Compliance, Life Sciences Transactions + Licensing, and Privacy + Data Security practice groups to ensure that life sciences companies remain compliant with all federal and state requirements. Please subscribe and follow our Life Sciences Blog, as we continue to update industry on new developments in compliance.
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.
© Morrison & Foerster LLP. All rights reserved
  © Mondaq® Ltd 1994 – 2022. All Rights Reserved.

Passwords are Case Sensitive

Forgot your password?
Free, unlimited access to more than half a million articles (one-article limit removed) from the diverse perspectives of 5,000 leading law, accountancy and advisory firms
Articles tailored to your interests and optional alerts about important changes
Receive priority invitations to relevant webinars and events
You’ll only need to do it once, and readership information is just for authors and is never sold to third parties.
We need this to enable us to match you with other users from the same organisation. It is also part of the information that we share to our content providers (“Contributors”) who contribute Content for free for your use.
Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.



Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top