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GUIDANCE DOCUMENT

Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older July 2024

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2018-D-0178
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients. Specifically, this guidance addresses FDA’s current thinking regarding clinical development programs that can support extrapolation of the efficacy of drugs approved for the treatment of POS in adults to pediatric patients 1 month of age and older. This guidance does not address the development of drugs to treat other types of seizures.

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All written comments should be identified with this document's docket number: FDA-2018-D-0178 .

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