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The new guidance document discusses reproductive toxicity testing and labeling recommendations.
FDA published guidance on May 9, 2019 regarding the evaluation of reproductive toxicity in oncology drugs. The guidance also provides labeling recommendations on the duration of contraception needed following the end of treatment.
The guidance discusses embryo-fetal development toxicity for various types of drugs and specific populations. The use of toxicity test results, knowledge of target biology, and available data on genetically modified animals is also addressed.
Specifically, the guidance touches on genotoxic drugs, biotechnology-derived drugs, conjugated drugs, combination products, and liposomal products. Assessment of effects on fertility, pre- and postnatal development, and use in specific populations is discussed.