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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author Schein, Yvette
Fernandez Lynch, Holly
author_facet Schein, Yvette
Fernandez Lynch, Holly
author_sort Schein, Yvette
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description 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.
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spelling pubmed-94535392022-09-24 Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II Schein, Yvette Fernandez Lynch, Holly JAMA Netw Open Research Letter 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. American Medical Association 2022-09-07 /pmc/articles/PMC9453539/ /pubmed/36069985 http://dx.doi.org/10.1001/jamanetworkopen.2022.30530 Text en Copyright 2022 Schein Y et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Research Letter
Schein, Yvette
Fernandez Lynch, Holly
Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II
title Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II
title_full Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II
title_fullStr Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II
title_full_unstemmed Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II
title_short Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II
title_sort use of clinical outcome assessments in new drug approvals by the us food and drug administration divisions of neurology i and ii
topic Research Letter
url 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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