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비즈니스 · 2018. 2. 13.1 분 읽기
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Guidance for Industry; Availability
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요약
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Bacillus Calmette-Gu[eacute]rin (BCG)-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment." This guidance was developed to assist in the development of drugs and biologics for patients with a form of bladder cancer that is not amenable to currently available medical therapy and remains an unmet medical need. This guidance finalizes the draft guidance of the same name issued on November 18, 2016.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →