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GUIDANCE DOCUMENT

E11A Pediatric Extrapolation August 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-1562
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.

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All written comments should be identified with this document's docket number: FDA-2022-D-1562.

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