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# Guide on Oncology Drug Reproductive Toxicity Testing
- URL: https://www.fdaweb.com/guide-on-oncology-drug-reproductive-toxicity-testing/
- Published: 2019-05-10T12:00:00.000Z
- Updated: 2026-09-15T01:25:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144084

*Federal Register* notice: FDA has made available a final guidance entitled “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.” The document is mainly focused on reproductive toxicity (embryo-fetal development), and it provides recommendations to applicants for pharmaceutical labeling on duration of contraception following therapy cessation to minimize potential risk to a developing embryo or fetus. The guidance also clarifies FDA’s current thinking on 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.govinfo.gov/content/pkg/FR-2019-05-10/pdf/2019-09691.pdf?ref=fdaweb.com).