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Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II

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This cross-sectional study examines drug approvals by the US Food and Drug Administration (FDA) Divisions of Neurology I and II to understand the role of clinical outcome assessments in regulatory… Click to show full abstract

This cross-sectional study examines drug approvals by the US Food and Drug Administration (FDA) Divisions of Neurology I and II to understand the role of clinical outcome assessments in regulatory decisions, including whether and how potential shortcomings are addressed.

Keywords: neurology; food drug; approvals food; drug administration; drug; drug approvals

Journal Title: JAMA Network Open
Year Published: 2022

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