E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population" (E11(R1) addendum or addendum). The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance is an addendum to the guidance published in 2000 entitled "E11 Clinical Investigation of Medicinal Products in the Pediatric Population" (ICH E11 (2000)), and provides updates to the original guidance. This addendum does not alter the scope of the original guidance, which outlines an approach to the safe, efficient, and ethical study of medicinal products in the pediatric population. This addendum complements and provides clarification and current regulatory perspective on topics in pediatric drug development. The guidance is intended to provide high-level guidance on the implementation of important approaches in pediatric drug development. This harmonized addendum will help to define the current recommendations and reduce the likelihood that substantial differences will exist amo