Pediatric drug development has evolved since the original guidance E11 Clinical Investigation
of Medicinal Products in the Pediatric Population (ICH E11 (2000)) published, requiring
consideration of regulatory and scientific advances relevant to pediatric populations. This
addendum does not alter the scope of the original guidance. ICH E11 (2000), including this
addendum (R1); is not intended to be comprehensive; other ICH guidances, as well as documents
from regulatory authorities worldwide, the World Health Organization (WHO), and pediatric
societies, provide additional detail. The purpose of the addendum is to complement and provide
clarification and current regulatory perspective on topics in pediatric drug development.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.