Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018

This cross-sectional study compares the duration of postapproval trials with that of the pivotal trials used as the basis for the US Food and Drug Administration’s (FDA’s) approval for all indications receiving accelerated approval from 2009-2018.

Detalles Bibliográficos
Autores principales: Wallach, Joshua D., Ramachandran, Reshma, Bruckner, Till, Ross, Joseph S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2021
Materias:
Research Letter
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579231/
https://www.ncbi.nlm.nih.gov/pubmed/34751764
http://dx.doi.org/10.1001/jamanetworkopen.2021.33601
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author Wallach, Joshua D.
Ramachandran, Reshma
Bruckner, Till
Ross, Joseph S.
author_facet Wallach, Joshua D.
Ramachandran, Reshma
Bruckner, Till
Ross, Joseph S.
author_sort Wallach, Joshua D.
collection PubMed
description This cross-sectional study compares the duration of postapproval trials with that of the pivotal trials used as the basis for the US Food and Drug Administration’s (FDA’s) approval for all indications receiving accelerated approval from 2009-2018.
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spelling pubmed-85792312021-11-23 Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018 Wallach, Joshua D. Ramachandran, Reshma Bruckner, Till Ross, Joseph S. JAMA Netw Open Research Letter This cross-sectional study compares the duration of postapproval trials with that of the pivotal trials used as the basis for the US Food and Drug Administration’s (FDA’s) approval for all indications receiving accelerated approval from 2009-2018. American Medical Association 2021-11-09 /pmc/articles/PMC8579231/ /pubmed/34751764 http://dx.doi.org/10.1001/jamanetworkopen.2021.33601 Text en Copyright 2021 Wallach JD 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
Wallach, Joshua D.
Ramachandran, Reshma
Bruckner, Till
Ross, Joseph S.
Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
title Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
title_full Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
title_fullStr Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
title_full_unstemmed Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
title_short Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
title_sort comparison of duration of postapproval vs pivotal trials for therapeutic agents granted us food and drug administration accelerated approval, 2009-2018
topic Research Letter
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579231/
https://www.ncbi.nlm.nih.gov/pubmed/34751764
http://dx.doi.org/10.1001/jamanetworkopen.2021.33601
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