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GUIDANCE DOCUMENT

E11 Clinical Investigation of Medicinal Products in the Pediatric Population December 2000

Final

E11 Clinical Investigation of Medicinal Products in the Pediatric Population

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

The number of medicinal products currently labeled for pediatric use is limited. This guidance is
intended to encourage and facilitate timely pediatric medicinal product development
internationally. The guidance provides an outline of critical issues in pediatric drug development
and approaches to the safe, efficient, and ethical study of medicinal products in the pediatric
population.
 


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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

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