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Cardiology
New data from C.M. Bakersmith et al illuminate research in cardiology
November 29th, 2008
According to recent research from the United States, " Congress has authorized the United States Food and Drug Administration (FDA) to provide industry sponsors with a 6-month extension of drug marketing rights under the Pediatric Exclusivity Provision if FDA-requested pediatric drug trials are conducted. The cost and economic return of pediatric exclusivity to industry sponsors has been shown to be highly variable." "We sought to determine the cost of performing pediatric exclusivity trials within a single therapeutic area and the subsequent economic return to industry sponsors. We evaluated 9 orally administered anti hypertensive drugs submitted to the FDA under the...
Source: Law & Health Weekly (2008-11-29)
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