May 04, 2018 - 10:30 AM - 11:20 AM EST

"Guidance on Guidance: FDA, DOJ, and Enforcement," Food and Drug Law Institute's Annual Conference: Exploring Advanced Topics in Food and Drug Law

This event has already occurred.
Ronald Reagan Building and International Trade Center
1300 Pennsylvania Avenue NW
Washington, DC 20004

In late January, then-Associate Attorney General Brand released a memorandum announcing that DOJ will not use its civil enforcement authority to enforce agency guidance documents. This has the potential to impact FDA-regulated industry, as non-compliance with guidance documents will not be used to establish violations of the law. In this session, panelists will look into the history of DOJ cases to see where this policy may have impacted prior actions and will also consider the potential implications for both industry and FDA moving forward.

Speakers:
Michael S. Blume, Partner, Venable LLP
Jennifer L. Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP and Vice Chair, FDLI Board of Directors
John H. Fuson, Partner, Crowell & Moring LLP

Visit the conference page for more information about this event.