FDA Sets Child Safety Rule After Death In Amgen Trial

Law360, New York (February 26, 2013, 5:03 PM EST) -- The U.S. Food and Drug Administration on Tuesday published a final rule strengthening safeguards for children enrolled in clinical trials on the same day it suspended pediatric trials of Amgen Inc.’s Sensipar following the death of a minor.

The agency halted all pediatric clinical trials of Amgen’s Sensipar, a drug used to treat a parathyroid condition, after a 14-year-old patient died during a study. The FDA said it was continuing to gather information on the incident and has not concluded whether or not Sensipar had a...
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