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
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
4/9/2019
/ Corporate Officers ,
Criminal Liability ,
Criminal Prosecution ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Legislative Agendas ,
Negligence ,
Park Doctrine ,
Proposed Legislation ,
White Collar Crimes
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 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 "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
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
On April 27, the Food and Drug Administration (FDA) released its promised draft guidance document, Multiple Function Device Products: Policy and Considerations, explaining how it will regulate multiple function devices that...more