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Imprese · 08/10/20201 min di lettura
Premenopausal Women With Breast Cancer: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
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Riepilogo
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Premenopausal Women with Breast Cancer: Developing Drugs for Treatment." This draft guidance provides recommendations regarding the inclusion of premenopausal women in breast cancer clinical trials.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.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →