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News from the FDA
Guidance Discusses Bundling Device Submissions
A recently released guidance titled “Bundling Multiple Devices or Multiple Submissions in a Single Submission” is intended to answer frequently asked questions about the FDA's policy on bundling multiple devices or multiple indications in a single premarket submission. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the bundling policy takes on additional importance because of the fees that are now associated with certain submissions as well as the performance goals the agency has committed to meet. The guidance is being issued as final for immediate implementation. A copy of the guidance document may be obtained at the Center for Devices and Radiological Health (CDRH) Web site at http://www.fda.gov/cdrh/.
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.