In general, this guidance focuses on the clinical pharmacology information that supports findings of effectiveness and safety and helps identify appropriate doses in pediatric populations.
This guidance does not describe:
(1) the standards for the approval of drugs in the pediatric population;
(2) the determination that the course of a disease is the same in adults and pediatric populations;
(3) the clinical pharmacology studies for the development of vaccine therapies, blood products, or other products not regulated by the Center for Drug Evaluation and Research.

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  • John Doe
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    November 12, 2017 at 1:38 pm

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