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GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2000-D-0942
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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-2000-D-0942.

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