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.
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
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