Regulatory Perspective-Presentation
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This presentation is intended to introduce a diverse audience to the complexity of the historical testing paradigm for developmental and reproductive toxicity testing and risk evaluation. Alternative methodological testing frameworks will need to be flexible and integrated in order to address the information requirements for various agencies and regulations. There is already significant movement towards incorporating mechanistic and ontological data into regulatory decision-making. The use of mechanistic data and a putative AOP in a WOE evaluation for effects of TCE on fetal cardiac development is shown as an example.