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Specifically, Demahy alleges that Actavis ignored scientific and medical literature establishing a higher risk of developing tardive dyskinesia, failed to request a labeling revision from the FDA, failed to change the label itself even though no prior FDA approval was required, and failed to report safety information directly to the medical community. The Fifth Circuit disagreed. The issue of adequate warnings on labels of generic drugs is an important issue because so many people are purchasing generic forms of drugs either because their health insurance plans require it, or simply because of the cost savings.

However, the labeling requirements of the FDA are significantly less stringent for generic drugs than they are for the original drug.

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New drug approval requires, among other deliverables, the results of successful clinical trials and labeling that accurately portrays the benefits and risks of the drug, as indicated by those trials and other data. Thanks to these Amendments, once a pioneer drug loses patent protection, a drug company may seek permission to market a generic version through a significantly simplified process, known as the abbreviated new drug application procedure, or ANDA. Generic drugs now account for seven out of ten prescriptions filled in the United States. Implied preemption comes in two forms: Field preemption is inferred where federal law is so pervasive that it leaves no room for state supplementation.

Courts have been particularly reluctant to find preemption in such cases without an unambiguous signal of congressional intent. And whom is Neel shutting out, herself or the viewer? Who is protecting whom? In the year of her own death, Neel was photographed by Robert Mapplethorpe. He later recorded that she asked to keep her eyes closed, "So I can see what I will look like when I'm dead. And when, inshe finally painted her first and only self-portrait, naturally she painted herself naked.

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