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Drug & Device News
FDA to Hold Public Hearing on Medication Guide Program
The Food and Drug Administration (FDA) will hold a public hearing on June 12 and 13 to gain feedback on the agency's Medication Guide program. (Medication Guides are handouts given to patients by pharmacists each time certain prescription drugs and biological products are dispensed. They contain FDA-approved patient information aimed at preventing serious adverse events.) Under current rules (21 CFR part 208), Medication Guides are required only if the drug has certain characteristics, such as a propensity to cause serious adverse health problems due to side effects or improper use. Currently, approximately 240 medications come with Medication Guides. The feedback received at the hearing will be used to assess the effectiveness of the guides and to discover and deal with their distribution challenges. For more information, please see: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01606.html.
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.