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GUIDANCE DOCUMENT

E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population April 2018

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.