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Ethical Considerations in Studying Drug Safety — The Institute of Medicine Report

The tumult arising from revelations of serious safety risks associated with widely prescribed drugs, including rosiglitazone (Avandia, GlaxoSmithKline), rofecoxib (Vioxx, Merck), and celecoxib (Celebrex, Pfizer), has led to widespread recognition that improvement is needed in our national system of ensuring drug safety. Notwithstanding federal legislation in 2007 that strengthened the authority of the Food and Drug Administration (FDA) in the postmarketing period, critical weaknesses in the national system persist.

For the full report see: http://www.nejm.org/doi/full/10.1056/NEJMhle1207160

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Bookmarked by dbogecho on 17 Sep 2012
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