Issue Date: November 26, 2024
Issued by: Oncology Center of Excellence
Topic(s):
Status: Draft
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This draft guidance provides recommendations to sponsors regarding the measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant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.
Download the Guidance Document
