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비즈니스 · 2014. 8. 6.1 분 읽기
In Vitro Companion Diagnostic Devices; Guidance for Industry and FDA Staff; Availability
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "In Vitro Companion Diagnostic Devices." This guidance is intended to assist sponsors who are planning to develop a therapeutic product for which the use of an in vitro companion diagnostic device is essential for the therapeutic product's safe and effective use as well as sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →