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Beyond central nervous system disorders, cognitive assessments will play vital roles in various therapeutic areas: Epilepsy studies will focus on cognitive impacts of seizures and medications Migraine research will examine cognitive function during and after episodes Phase I trials will incorporate cognitive testing for neurological safety monitoring Heart failure studies will track cognitive function as a key comorbidity measure In these ways, the proliferation in adoption of cognitive testing will support more accurate and patient-centered clinical data

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If the issues and deficiencies cant be addressed through an interactive review, then FDA will send the manufacturer an Additional Information request