Science & Research
16 April 2012 Public Workshop on Reproductive and Developmental Toxicology: From In Vivo to In Vitro
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Webcast Afternoon Sessions:
To bring scientific information about new in vitro technologies for toxicology testing to FDA and to explore how novel technologies could eventually be integrated into FDA's regulatory model, the Agency and its cosponsors, the National Institutes of Health (NIH), the National Institute for Environmental Health Sciences (NIEHS), the Center for Alternatives to Animal Testing, Johns Hopkins School of Public Health (CAAT), and the Middle Atlantic Reproduction and Teratology Association (MARTA) held a training workshop on April 16, 2012 on Reproductive and Developmental Toxicology: From In Vivo to In Vitro.
This workshop is part of FDA efforts like the Critical Path2 and Advancing Regulatory Science3 Initiatives to develop new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. An essential facet of this effort involves raising awareness about the complex challenges these technologies present for FDA scientists, encouraging dialogue between FDA and its partners, and bringing together scientific views that can serve as references for FDA initiatives.
Assessing safety is particularly challenging in the reproductive/developmental toxicology field due to the reproductive cycle's complexity and unusually long time frame. Current animal testing requirements call for two animal studies: a 2-generation study in rats and in rabbits. The 2-generation study is among the most costly of toxicology tests and uses up to 3,200 animals per substance. Furthermore, pronounced inter-species variances have been described showing not more than 60% correlation between different laboratory mammalian species in the developmental toxicity area.