Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs

BACKGROUND: We examined how often new serious safety signals were identified by the U.S. Food and Drug Administration within the first 2 years after approval for new molecular entities (NMEs) for treatment of cancer that required specific regulatory actions described here. METHODS: We identified, fo...

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Detalhes bibliográficos
Publicado no:Oncologist
Main Authors: Kim, Janice, Nair, Abhilasha, Keegan, Patricia, Beaver, Julia A., Kluetz, Paul G., Pazdur, Richard, Chuk, Meredith, Blumenthal, Gideon M.
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley & Sons, Inc. 2019
Assuntos:
Regulatory Issues: FDA
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7160417/
https://ncbi.nlm.nih.gov/pubmed/32297444
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2019-0653
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