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E11A Pediatric Extrapolation August 2022


Not for implementation. Contains non-binding recommendations.

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

The purpose of this guideline is to provide recommendations for, and promote international harmonization of, the use of pediatric extrapolation to support the development and authorization of pediatric medicines. Harmonization of the approaches to pediatric extrapolation should reduce the likelihood of substantial differences between regions. Importantly, harmonization should also reduce exposure of pediatric populations to unnecessary clinical trials and facilitate more timely access to pediatric medicines globally.

Submit Comments

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-2022-D-1562.

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