Pediatric Drug Development: FDA Requirements

Under the Pediatric Drug Development Website, the FDA Center for Drug Evaluation and Research (CDER) has summarised all important links to applicable Regulations, Guidances and other important information.

The 2007 Best Pharmaceuticals for Children Act calls for medical, statistical and clinical pharmacology reviews of pediatric studies. These reviews are for example also published here.

Other interesting information is given in various presentations by CDER staff on pediatric issues, beginning in 1999 and reflecting the role of the FDA and the development of the regulatory framework. However the latest presentation published dates from July 2004. More current information is given in the other sections on the homepage.

Compiled by Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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