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U.S. Department of Health and Human Services

About FDA

Modernize Toxicology Testing

Description: Animal studies are used during medical product development to predict toxicity in humans. These studies are time-consuming and rely heavily on testing approaches from the past century. New technologies (e.g., cell-based testing, computer modeling) are available, but need to be further explored, refined, and validated. ORSI is supporting efforts to develop testing approaches that reduce the number of animals needed for toxicology testing, use of lower animal species, use non-animal based toxicology models, improve predictability, make nonclinical studies more efficient, and, ultimately, reduce the time needed to initiate and complete clinical testing. As part of this effort, a request for application (RFA) is in planning for 2011 to identify collaborative partners in support of developing and validating modern toxicology testing approaches.

Accomplishment: Through the RFA mechanism we have awarded funding to 2 scientists to help support the development and validation of biomarkers specific to reproductive toxicity. Reproductive toxicity refers to the effects associated with some substances that can interfere with normal sexual function and fertility in adult males and females; reproductive toxicity can also cause developmental toxicities in offspring. It is critical to identify reproductive toxicities early in drug development before clinical testing in humans. The following two grantees were chosen:

  • Elaine Faustman, University of Washington – 3D Testicular Cells Co-Culture Model for Reproductive and Developmental Toxicity
  • Thomas Hartung, Johns Hopkins University – Developmental Neurotoxicity for High Throughput Testing by Metabolomics

  • Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

    A. Establish FDA working group

    12/30/2010

    Completed 11/30/2010

    B. Develop Request for Application (RFA)

    7/31/2011

    Completed 2/17/2011

    C. Issue RFA

    8/30/2011

    Completed 4/28/2011

    D. Establish review panel to evaluate applications

    6/30/2011

    Completed 7/12/2011

    E. Make awards

    9/30/2011

    Completed 9/16/2011

    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

    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.