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Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019
IMPORTANCE: After US Food and Drug Administration (FDA) approval of a new drug, sponsors can submit additional clinical data to obtain supplemental approval for use for new indications. OBJECTIVE: To characterize pivotal trials supporting recent supplemental new indication approvals of drugs and bio...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8193429/ https://www.ncbi.nlm.nih.gov/pubmed/34110392 http://dx.doi.org/10.1001/jamanetworkopen.2021.13224 |