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비즈니스 · 2020. 10. 8.1 분 읽기
Premenopausal Women With Breast Cancer: Developing Drugs for Treatment; Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Premenopausal Women with Breast Cancer: Developing Drugs for Treatment." This draft guidance provides recommendations regarding the inclusion of premenopausal women in breast cancer clinical trials. The guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials for breast cancer drugs.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →