CDRH Industry: Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays - Guidance for Industry and Food and Drug Administration Staff

The guidance "Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays" contains recommendations to manufacturers and FDA reviewers concerning information to include in premarket notifications for assays for the anti-seizure drugs lamotrigine and zonisamide.