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U.S. Department of Health and Human Services

About FDA

New Technologies for Safety Assessments

Description: Utilize new genomics and other molecular technologies and approaches for evaluating FDA-regulated products for adverse genetic effects. This is a collaborative effort with CDRH and CFSAN.

Definition: DGMT focuses on the development and validation of new methods to assess genetic risk. New molecular technologies are being developed and can be used to evaluate structural and functional changes to the genetic material of both rodents and humans.

An increased understanding of mutational mechanisms and test systems that have an increased ability to detect genetic damage, etc. will provide FDA with better information for decision-making. In the future, these new approaches to evaluate toxicity will allow for the integration of information across the various types of adverse health outcomes. For instance, when these technologies are fully developed, it will be possible to concurrently evaluate chemicals for their ability to cause cancer, to impact the nervous system, to cause birth defects, and to modify the immune function.

Public Health Outcome: When developed and validated, this new assay which helps to distinguish between chemicals that can cause genetic damage/cancer and those that are safe will provide a better method for use in FDA product safety evaluations such as preclinical safety evaluation for pharmaceuticals.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Present and discuss new technologies for safety assessments with the scientific community at the Society for Toxicology Meeting

3/31/2010

Completed 3/31/2010

2. Complete and accept review article describing the potential for microRNA analysis to be useful in evaluating whether a new drug or other chemical is a carcinogen

5/31/2010

Completed 5/31/2010

3. Approve protocol to develop a new project to assess the utility of gene expression analysis to evaluate whether a new drug or chemical is a carcinogen

6/30/2010

Completed 6/30/2010

4. Complete the hiring process for a new support research scientist to assist in developing new molecular technologies

7/30/2010

Completed 7/30/2010

5. Complete training for support scientist for the microRNA/gene expression project

8/30/2010

Completed 8/30/2010

6. Present and discuss research from gene expression studies at the Environmental Mutagen Society Meeting

10/31/2010

Completed 10/31/2010

7. Present and discuss research at ILSI/HESI Workgroup Meeting

10/20/2011

Completed 10/20/2011

8. Complete research

12/31/2012

On Track

9. Complete the assessment of research findings

TBD

Not Yet Started

10. Develop draft technical report/manuscript/publication

TBD

Not Yet Started

11. Complete the peer review (NCTR and other researchers) of draft technical report, manuscript, and/or publication

TBD

Not Yet Started

12. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

TBD

Not Yet Started

13. Submit final technical report, manuscript and/or publication to a scientific journal

TBD

Not Yet Started

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

genomics

high throughput technologies used to analyze the products made by all of the genes or a subset of the genes in a cell

CDRH

Center for Devices and Radiological Health

CFSAN

Center for Food Safety and Applied Nutrition

microRNA

micro Ribonucleic acid

gene expression analysis

an analysis of the products made by genes

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.