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News from the FDA
Initiative to Heighten Battle Against Counterfeit Drugs
Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., announced a major new initiative to more aggressively protect American consumers from drugs that have been counterfeited (July 16). The new initiative includes creating an internal task force to explore the use of modern technologies and other measures such as stronger enforcement that will make it more difficult for counterfeit drugs to get distributed with, or deliberately substituted for, safe and effective drugs. The task force will submit its initial findings and recommendations in approximately 60 days and will issue a final report 5 months from now, after it has had the opportunity to hear from the public.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
Compliance Officers: Recent Regulatory Guidance and Enforcement Actions and Mitigating the Risk of Personal Liability
This article explores legal developments over the past year that may impact compliance officer personal liability.