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

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.

Detalles Bibliográficos
Autores principales: Schein, Yvette, Fernandez Lynch, Holly
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2022
Materias:
Research Letter
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9453539/
https://www.ncbi.nlm.nih.gov/pubmed/36069985
http://dx.doi.org/10.1001/jamanetworkopen.2022.30530

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