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U.S. Department of Health and Human Services

Science & Research

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Public Workshop on Reproductive and Developmental Toxicology: From In Vivo to In Vitro

April 16, 2012
8:00am-5:30pm EST

The Food and Drug Administration (FDA), National Institutes of Health, National Institute for Environmental Health Sciences, the Center for Alternatives to Animal Testing, Johns Hopkins School of Public Health (CAAT), and the Middle Atlantic Reproduction and Teratology Association (MARTA) are cosponsoring a training workshop titled Reproductive and Developmental Toxicology: From In Vivo to In Vitro on April 16, 2012.

The workshop's objectives are twofold: 1) to bring scientific information about new in vitro technologies for reproductive and developmental toxicology testing to FDA and 2) to provide a forum for scientists from FDA, academia, and industry to discuss how these new technologies could eventually be integrated into FDA's regulatory paradigm.

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.

It is anticipated that this training will help speed the regulatory review of these new technologies and ensure that they are adequately validated and well controlled.  This workshop supports FDA efforts, such as the Critical Path and Advancing Regulatory Science Initiatives, to develop new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all 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.

Workshop location:
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Great Room, Building 31
Silver Spring, MD 20993

Registration:
There is no registration fee for the public workshop. Early registration is recommended because seating is limited. To register, please send your name, affiliation, and email to OCSFDAWORKSHOP@fda.hhs.gov.  Email your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by April 2, 2012.

Contact Person: Suzanne Fitzpatrick, PhD, DABT

Webcasting will be available at https://collaboration.fda.gov/reprotox/

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