Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021

IMPORTANCE: The US Food and Drug Administration (FDA) has 4 programs that can be used alone or in combination to expedite drug availability: Accelerated Approval, Breakthrough Therapy, Fast Track, and Priority Review. Drugs using these programs can include novel drugs, which do not contain a previou...

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Detalles Bibliográficos
Autores principales: Monge, Andrea N., Sigelman, Daniel W., Temple, Robert J., Chahal, Harinder Singh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2022
Materias:
Original Investigation
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9627417/
https://www.ncbi.nlm.nih.gov/pubmed/36318210
http://dx.doi.org/10.1001/jamanetworkopen.2022.39336

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9627417/
https://www.ncbi.nlm.nih.gov/pubmed/36318210
http://dx.doi.org/10.1001/jamanetworkopen.2022.39336

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