E11A Pediatric Extrapolation

On 26 August 2022 the FDA published draft guidance on ICH E11A.

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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