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Duke University Medical Center
Post-marketing studies finding adverse events in drugs used in children
September 20th, 2008
The Food and Drug Administration Modernization Act (FDAMA, 1997), designed to stimulate more drug safety studies in children, has resulted in more than 130 label changes since its inception nearly six years ago, according to researchers at Duke Children's Hospital. 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,...
Source: Law & Health Weekly (2008-09-20)
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