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Negócios · 10/06/20161 min de leitura
Oncology Drugs for Companion Animals; Draft Guidance for Industry; Availability
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Resumo
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #237 entitled "Oncology Drugs for Companion Animals." The guidance provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a new animal drug application (NADA) for certain oncology drugs, and provides recommendations on how to address human user safety concerns.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →