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U.S. Department of Health and Human Services

About FDA

Nanotechnology

Description: Develop policies and procedures on how to properly review nanotechnology submissions and handle industry inquiries. This project was recommended by the Office of the Commissioner in response to an anticipated increase in the number of nanotechnology based products that CVM regulates.

Accomplishment: CVM developed Nanotechnology Policies and Procedures (P&P) in order to strengthen product evaluation capabilities, and ensure a scientifically valid, predictable, and effective process for the review of novel technologies. The Nanotechnology Policies and Procedures include a consistent methodology for regulating nano-scale products. CVM also developed a mechanism to track products that utilize this new technology. CVM anticipates an increase in the number of new animal drugs employing nanotechnology. Properly addressing critical safety and effectiveness questions pertinent to this technology ensure public and animal health protection.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Prepare an initial draft of Nanotechnology P&P

2/28/2010

Completed 2/17/2010

2. Create method for tracking nano-scale products

3/31/2010

Completed 3/17/2010

3. Finalize Nanotechnology P&P for ONADE comment

6/30/2010

Completed 4/26/2010

4. Implement Nanotechnology P&P in ONADE

8/31/2010

Completed 8/24/2010

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

ONADE

Office of New Animal Drug Evaluation

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.