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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...
Autores principales: | Monge, Andrea N., Sigelman, Daniel W., Temple, Robert J., Chahal, Harinder Singh |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2022
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Materias: | |
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 |
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