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... the FDA's interim rule.(clinical safeguards for children participating in clinical trials)
The US Food and Drug Administration (FDA) issued an interim rule last month providing additional safeguards for children participating in clinical studies of FDA-regulated products. The rule, which has been issued in response to "expected increases in the enrollment of children in clinical investigations as a result of recent pediatric initiatives," grants institutional review boards(IRBs) permission to approve, suspend or terminate clinical studies based on the level of risk associated with the study. However, the rule allows IRBs to approve only those clinical investigations that are of better, or at least equivalent, therapeutic ...
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