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
(2) the determination that the course of a disease is the same in adults and pediatric
(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.
Click here> for the guidance..