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Drug & Device News
FDA Issues Guidance on Hospital Bed Design
Elderly patients in hospitals and nursing homes are prone to entrapment in their beds, which has resulted in a reported 413 deaths in the past 21 years. To study and combat this problem, the Food and Drug Administration (FDA), Veterans Administration, Health Canada's Medical Devices Bureau and representatives of several other groups formed an organization in 1999 known as the Hospital Bed Safety Workgroup (HBSW). Their recommendations have just recently been published in an FDA final guidance entitled 'Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.' The final guidance offers suggestions for health care facilities on ways to assess the safety of their existing beds by identifying the locations of hospital bed openings that are potential entrapment areas. It also offers recommendations for how to choose new hospital bed systems. The guidance is available on the FDA's Web site at: http://www.fda.gov/cdrh/beds/.
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.
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.