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# Toxicity Testing, Labeling Guidance Out
- URL: https://www.fdaweb.com/toxicity-testing-labeling-guidance-out/
- Published: 2017-09-28T12:00:00.000Z
- Updated: 2026-09-14T22:53:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139739

FDA has published a draft guidance, *Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations*, to assist sponsors in reproductive toxicity assessments (mainly of embryo-fetal development (EFD)) for anti-cancer pharmaceuticals. It also provides recommendations for product labeling on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo/fetus. Concepts discussed in the [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM577552.pdf?ref=fdaweb.com) are: 

- evaluation of EFD toxicity for various types of pharmaceuticals and when such studies are not needed;
- evaluation of EFD toxicity for pharmaceuticals intended for specific populations;
- use of nonclinical information such as results of genotoxicity and general toxicity studies in assessing the need for a dedicated EFD study; and
- labeling recommendations concerning EFD studies and the potential risk for adverse development outcomes in humans (Pregnancy subsection of labeling) and recommendations for contraception in male and female patients to minimize risk to a developing embryo/fetus (Females and Males of Reproductive Potential subsection of labeling).