Duke University Medical Center
Post-marketing studies finding adverse events in drugs used in children
Published in Medical Letter on the CDC and FDA, September 21st, 2008
Their analysis appears in the September issue of Pediatrics.
Under this and subsequent renewal of this legislation, pharmaceutical companies were given a six-month extension of their exclusive marketing rights on a drug if they performed clinical trials requested by the FDA to determine the drugs' safety, dosing, and efficacy in children.
According to P. Brian Smith,...
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