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GUIDANCE DOCUMENT

E11A Pediatric Extrapolation December 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2022-D-1562
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “E11A Pediatric Extrapolation.”  The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).  The guidance provides a comprehensive and systematic approach to pediatric extrapolation during drug development.  Notably, the guidance discusses approaches to safety extrapolation and defining extrapolation as a continuum.  The guidance also includes approaches to study designs and statistical methodologies, including modeling and simulation, for developing and implementing pediatric extrapolation.  The guidance is intended to provide approaches that can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children.  The guidance replaces the draft guidance “E11A Pediatric Exploration” issued on August 29, 2022.

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

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