Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older Guidance for Industry

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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