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비즈니스 · 2022. 3. 2.1 분 읽기
Expansion Cohorts: Use in First-in-Human Clinical Trials To Expedite Development of Oncology Drugs and Biologics; Guidance for Industry; Availability
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요약
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final 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 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 oncology drugs, including biological products, through multiple expansion cohort trial designs. This guidance finalizes the draft guidance of the same name issued in August 2018.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →