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  1. Science & Research (NCTR)

Genetic and Molecular Toxicology Also referred to as: DGMT

The Division promotes public health by providing FDA with the expertise and tools necessary for comprehensive assessments of genetic risk and by strengthening approaches to integrate knowledge of genetic risk into regulatory decision-making.

Genetic and Molecular Toxicology

Mission

Provide internationally recognized expertise in developing, validating, and interpreting genetic toxicology research for regulatory decisions that improve public health.


Director: Robert Heflich, Ph.D.

DGMT Scientist

Division Research Themes

  1. Development, validation, and maintenance of regulatory genetic-toxicology assays
  2. Chemical-specific research
  3. Development of new paradigms for regulatory decision-making that integrate measures of genetic risk with biomarkers of toxicity by conducting research involving:
    • Advanced more relevant biological models
    • Comprehensive approaches to monitoring genetic variation using technologies such as Next Generation Sequencing (NGS)
    • New approaches for evaluating data to determine human risk 

The Division promotes public health by providing FDA with the expertise and tools necessary for comprehensive assessments of genetic risk and by strengthening approaches to integrate knowledge of genetic risk into regulatory decision-making. Division research is directed towards improving existing methods, and towards developing and validating new methods for evaluating high-priority issues related to the toxicity of food additives, human and animal drugs, biological therapies, nanomaterials, dietary supplements, tobacco products, botanicals, and medical devices. Division scientists actively participate in FDA committees and international working groups that form consensus on how to conduct regulatory genetic toxicology testing. These groups include the FDA GeneTox Network, FDA/CDER’s Genetic Toxicology Subcommittee, the International Workshop for Genotoxicity Testing (IWGT), the Organization for Economic Co-Operation and Development (OECD), and the International Life Sciences Institute/Health and Environmental Sciences Institute (ILSI/HESI).

NCTR's Annual Report contains information on the latest accomplishments and plans for the Division of Genetic and Molecular Toxicology as well as project and publication listings.
 

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Contact Us

Contact Point
NCTR
National Center for Toxicological Research
Food and Drug Administration
3900 NCTR Rd
Jefferson, AR 72079
Hours Available
(870) 543-7391