Analysis of FDA's Accelerated Approval Program Performance December 1992–December 2021

The accelerated approval pathway has been criticized recently for employing lower regulatory standards than traditional drug approval, undue delays in withdrawing approvals of drugs for which studies have not confirmed clinical benefit, and confirmatory trials not being pursued with due diligence. T...

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Detalles Bibliográficos
Autores principales: Beakes-Read, Ginny, Neisser, Madison, Frey, Patrick, Guarducci, Mara
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9332089/
https://www.ncbi.nlm.nih.gov/pubmed/35900722
http://dx.doi.org/10.1007/s43441-022-00430-z

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9332089/
https://www.ncbi.nlm.nih.gov/pubmed/35900722
http://dx.doi.org/10.1007/s43441-022-00430-z

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