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Drug & Device News
'Dietary Supplements' Promoted for Sexual Enhancement May Be Dangerous
The U.S. Food and Drug Administration (FDA) is warning consumers not to use what have been advertised as 'dietary supplements' for treating erectile dysfunction (ED) and enhancing sexual performance: Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON. 'These products threaten the public health because they contain undeclared chemicals that are similar or identical to the active ingredients used in several FDA-approved prescription drug products,' said Dr. Steven Galson, Director of the FDA's Center for Drug Evaluation and Research. 'This risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure.' The FDA's chemical analysis of Zimaxx revealed that it contains sildenafil, which is the active pharmaceutical ingredient in the prescription drug Viagra.' The other products contain chemical ingredients that are analogues of either sildenafil or a pharmaceutical ingredient called vardenafil. This is the active ingredient in Levitra', a prescription drug that, like Viagra, is approved in the United States to treat ED. There is no mention of any of these ingredients in any of the illegal products' labeling.
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.