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News from the FDA
New Rules On Development of Veterinary Drugs That Can Affect Food Supplies
Of interest to veterinary medicine manufacturers is a final guidance document issued by the FDA titled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing” (VICH GL28). The guidance was adapted for veterinary use by the International Cooperation on Harmonisation of Technical Require-ments for Registration of Veterinary Medicinal Products (VICH) from a guidance regarding pharmaceuticals for human use. It's intended to help ensure that residues of veterinary drugs in animal products for human consumption are not too carcinogenic and applies to food in the European Union, Japan, and the United States. Copies of the document may be obtained on the Internet from the CVM home page at http://www.fda.gov/cvm. For more information, see Docket No. 2001D-0357 at http://a257.g.akamaitech.net/ 7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-11781.htm
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.
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.
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.
CLE Shouldn't Be the Only Mandatory Training for Attorneys
Each stage of an attorney's career offers opportunities for a curriculum that addresses both the individual's and the firm's need to drive success.
Discovery of Claim Construction and Infringement Analysis May be Compelled Prior to a Markman Hearing
A defendant in a patent infringement suit may, during discovery and prior to a <i>Markman</i> hearing, compel the plaintiff to produce claim charts, claim constructions, and element-by-element infringement analyses.