Navigating regulatory challenges in pediatric epilepsy pharmacotherapy: pathways to safe and effective treatments

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Narrative review explores FDA and EMA frameworks for pediatric antiseizure medications, highlighting challenges.

Development of new antiseizure medications faces significant regulatory and financial barriers, impacting pediatric epilepsy care.
The narrative review identifies pediatric drug development history and current FDA and EMA regulations for antiseizure medications.
A focused approach can help meet true pediatric needs and accelerate the development of innovative epilepsy treatments.
Incentives must align with childhood-specific syndromes and age-appropriate pharmacology to improve drug availability.

Villano et al. (2025) studied this question.

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