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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this article discussed the background of REMS (Risk Evaluation and Mitigation Strategies) and provided a summary of the Draft Guidance.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.
Features
This article outlines some of the essential advantages, and the challenges, in constructing an effective in-house training program.
Features
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."
Features
Federal district court judge Shira A. Scheindlin has given preliminary approval to a settlement between a class of plaintiffs whose names are on the state's child abuse registry and the New York State Office of Children and Family Services.
Last month, we discussed a Texas case in which the the spouse of a military service member had her share of her husband's military retirement cut off by the retiree's decision to opt for disability payments instead. Herein, we discuss the situation in New York.
