Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond

In 2021, policy areas of focus for FDA Oncology included the Accelerated Approval programme, expanding eligibility criteria, dose optimization and patient-reported outcomes. The FDA continued to be active with approvals of both new drugs and supplementary applications, including three new chimeric a...

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Detalles Bibliográficos
Autores principales: Lemery, Steven, Pazdur, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
Materias:
Comment
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8824437/
https://www.ncbi.nlm.nih.gov/pubmed/35136230
http://dx.doi.org/10.1038/s41571-022-00605-5
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author Lemery, Steven
Pazdur, Richard
author_facet Lemery, Steven
Pazdur, Richard
author_sort Lemery, Steven
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description In 2021, policy areas of focus for FDA Oncology included the Accelerated Approval programme, expanding eligibility criteria, dose optimization and patient-reported outcomes. The FDA continued to be active with approvals of both new drugs and supplementary applications, including three new chimeric antigen receptor T cell products, two antibody–drug conjugates and several new targeted agents.
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spelling pubmed-88244372022-02-09 Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond Lemery, Steven Pazdur, Richard Nat Rev Clin Oncol Comment In 2021, policy areas of focus for FDA Oncology included the Accelerated Approval programme, expanding eligibility criteria, dose optimization and patient-reported outcomes. The FDA continued to be active with approvals of both new drugs and supplementary applications, including three new chimeric antigen receptor T cell products, two antibody–drug conjugates and several new targeted agents. Nature Publishing Group UK 2022-02-08 2022 /pmc/articles/PMC8824437/ /pubmed/35136230 http://dx.doi.org/10.1038/s41571-022-00605-5 Text en © This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2022 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Comment
Lemery, Steven
Pazdur, Richard
Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
title Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
title_full Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
title_fullStr Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
title_full_unstemmed Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
title_short Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
title_sort approvals in 2021: dangling accelerated approvals, drug dosing, new approvals and beyond
topic Comment
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8824437/
https://www.ncbi.nlm.nih.gov/pubmed/35136230
http://dx.doi.org/10.1038/s41571-022-00605-5
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