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Supreme Court to Confront FDA Pre-emption and the Consequences of 'Overwarning'
In 2008, the U.S. Supreme Court will likely decide a key question that has driven FDA pre-emption debates over the past decade: whether ' as plaintiffs' counsel maintain ' warning labels for FDA-approved drugs and medical devices provide only 'minimum standards,' or whether ' as the FDA insists ' they provide a balanced judgment of the FDA, setting both a floor and a ceiling on safety warnings. This article reviews the legal issues facing the Court in a series of FDA pre-emption cases before it. It then discusses the central flaw in plaintiffs' 'minimum standards' argument, drawing on a series of recent scientific and medical developments that highlight how 'overwarnings' can have significant, real-world, adverse consequences with respect to public health.
FDA Pre-emption Issues Currently Facing the Supreme Court
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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.
How AI Has Affected PR
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.
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.