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비즈니스 · 2018. 8. 13.1 분 읽기
Expansion Cohorts: Use in First-In-Human Clinical Trials To Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry; Availability
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요약
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics." The purpose of this draft guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical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.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →