Premenopausal Women With Breast Cancer: Developing Drugs for Treatment; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Premenopausal Women with Breast Cancer: Developing Drugs for Treatment." This 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. This guidance finalizes the draft guidance of the same title issued on October 8, 2020.