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:

• Evaluation of EFD toxicity for various types of pharmaceuticals • Evaluation of EFD toxicity for pharmaceuticals intended for specific populations

` • Use of available information, such as the results of genotoxicity and general toxicity studies, knowledge of target biology, and available data on genetically modified animals in assessing the need for a dedicated EFD study

 • Labeling recommendations for duration of contraception in male and female patients to minimize risk to a developing embryo or fetus (Females and Males of Reproductive Potential subsection of labeling)