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The draft guidance gives recommendations for reproductive toxicity testing and labeling.
On Sept. 28, 2017, FDA published draft guidance on reproductive toxicity testing and labeling of oncology pharmaceuticals. The guidance discusses embryo-fetal development (EFD) toxicity, results of genotoxicity and general toxicity studies, and labeling recommendations concerning EFD studies and the potential risk of adverse development outcomes.
Risks from biosimilar products, interchangeable products, radio-pharmaceuticals, cellular and gene therapy products, or cancer vaccines are not addressed in the guidance. It also does not discuss margins of safety by exposure or dose.
The FDA guidance complements International Council for Harmonization (ICH) guidance and provides examples of alternative assessments and additional recommendations not described in ICH guidelines.