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Negócios · 13/08/20181 min de leitura
Expansion Cohorts: Use in First-In-Human Clinical Trials To Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics." The purpose of this draft guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of cancer drugs, including biological products, through multiple expansion cohort study designs.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →