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 industries, where guidance documents are often the primary source of information, even though DOJ states that non-compliance with guidance documents will not be used to establish violations of the law. During this webinar, speakers will look into the history of DOJ cases to see where this policy may have impacted prior actions and will also consider the 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