- Docket Number:
- FDA-2024-D-4643
- Issued by:
-
Guidance Issuing Office
Oncology Center of Excellence
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
This draft guidance provides recommendations to sponsors regarding the measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant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.
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Food and Drug Administration
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Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2024-D-4643.
