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# Guide on Oncology Reproductive Toxicity Testing
- URL: https://www.fdaweb.com/guide-on-oncology-reproductive-toxicity-testing/
- Published: 2017-09-29T12:00:00.000Z
- Updated: 2026-09-14T22:53:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139746

*Federal Register* notice: FDA has made available a draft guidance entitled “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.” The document is intended to assist sponsors in reproductive toxicity assessments (mainly of embryo-fetal development) for oncology pharmaceuticals and to provide recommendations for product labeling on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo/fetus. It also clarifies when nonclinical studies for reproductive toxicology assessment may not be needed (e.g., for pharmaceuticals intended for use in postmenopausal women only). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-09-29/pdf/2017-20906.pdf?ref=fdaweb.com).