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Practice Tip: The Physician Labeling Rule
On June 30, 2006, new regulations governing the format and content of prescription drug labels went into effect. These changes marked the first major overhaul of drug labeling rules in more than 25 years.
The primary purpose of the changes is to make labels more accessible to practicing physicians. When the FDA first issued the rule in December 2000, it expressed concern that product labels had become too cluttered as a result of growing chemical complexity of drugs and the effects of product liability litigation. The new label, including a 'highlights' section, a table of contents, and a streamlined adverse reaction section, is designed to return the product label to its originally intended purpose as a useful and clear tool for practicing physicians.
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.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.
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.