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Justice Department Updates Self-Disclosure Policy; Deputy AG Announces Further Requirements

On February 22, 2023, the Department of Justice (DOJ) announced an update of its Voluntary Self-Disclosure Policy applicable to all United States Attorneys’ Offices in their prosecution decisions, effective immediately. The...more

The Proposed Corporate Executive Accountability Act - Bending the Space-Time Continuum to Find Criminal Culpability of Corporate...

Two core principles of American criminal liability are: (1) a crime does not occur unless the accused has both criminal intent (mens rea) and commits a criminal act (actus reus); and (2) the intent and the act must occur at...more

The PCAOB Wants to Talk to the Audit Committee Chair—Now What?

The Public Company Accounting Oversight Board (PCAOB) recently noted that it will provide an opportunity for audit committee chairs of certain companies whose audits are subject to inspection to “engage in a dialogue with the...more

The PCAOB Wants to Talk to the Audit Committee Chair – Now What?

The PCAOB recently noted that during 2019 it will provide an opportunity for audit committee chairs of certain companies whose audits are subject to inspection to “engage in a dialogue with the inspections staff.” ...more

FDA's Plans to Fundamentally Modernize the 510(k) Process

FDA's "510(k)" process, by which a medical device manufacturer can bring a product to market based on the premise that the proposed device is the substantially equivalent to a an already legally marketed "predicate device",...more

Don't Bet On It: Interstate Sports Betting Markets Hampered by Federal Wire Act

The sports betting legal market dramatically shifted when the U.S. Supreme Court struck down the Professional and Amateur Sports Protection Act (PASPA) as unconstitutional commandeering under the 10th amendment. PASPA...more

FDA Digital Health Update: Multiple Function Devices

On April 27, the Food and Drug Administration (FDA) released its promised draft guidance document, Multiple Function Device Products: Policy and Considerations, explaining how it will regulate multiple function devices that...more

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