Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products." This draft guidance provides recommendations to sponsors regarding the measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant cancer clinical trials that enroll premenopausal adults with ovaries. Assessment of ovarian toxicity in cancer trials helps ensure that patients and clinicians have information about the possible long-term impacts of treatment on ovarian function and thus facilitate informed decision- making regarding anti-cancer agents.