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:
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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
Descripción
Sumario: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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