Issue Date: May 10, 2019
Issued by: Center for Drug Evaluation and Research
Topic(s): Pharmacology/Toxicology
Status: Final
Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry: Guidance for Industry
The purpose of this guidance is to assist sponsors in evaluating reproductive toxicity (mainly for effects on embryo-fetal development (EFD)) 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 or fetus. This guidance is intended to facilitate the development of oncology pharmaceuticals while avoiding unnecessary use of animals, in accordance with the 3R (reduce, refine, replace) principles. The following concepts are discussed in this guidance:
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