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비즈니스 · 1998. 2. 12.1 분 읽기
Draft Guidance for Industry on Environmental Assessment of Human Drug and Biologics Applications; Availability
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요약
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Environmental Assessment of Human Drug and Biologics Applications.'' This draft guidance is intended to provide information on when an environmental assessment (EA) should be submitted in support of a human drug or biologics application and recommendations on how to prepare EA's.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →