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The U.S. Court of Appeals for the Eighth Circuit recently held that "failure to warn" claims brought against generic manufacturers of Reglan' (a prescription drug used to treat certain gastric disorders) were not preempted by federal law and could, therefore, proceed to discovery.
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The first part of this article discussed the background of REMS (Risk Evaluation and Mitigation Strategies) and provided a summary of the Draft Guidance. The conclusion herein explains the second part of the procedure, including proposed modifications and communicating with the FDA.
How much attorney involvement in the drafting of experts' reports is permissible? Must the entire work product be that of the expert? Or, at the other extreme, would it be acceptable for an attorney to draft the entire expert's report with the expert "adopting" it?
Habitual responses quickly turn into behavioral practices. Too frequently, inappropriate conditioned responses escalate to bad habits due to frequency of use and lack of awareness. What can be done?
Firms of all sizes are faced with increased competition and increased client demands ' and consensus management is ill-equipped to deal with the new environment. There are several reasons for this, discussed herein.
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This article outlines some of the essential advantages, and the challenges, in constructing an effective in-house training program.
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The vision of this article is to provide a model that may be used in discussing how a firm can power into the next few years. It uses a watershed analogy to demonstrate drivers for higher margins and the skills required to maximize each stream of effort running toward the earnings "lake."