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U.S. Department of Health and Human Services

About FDA

Neglected/Tropical Disease Initiative

Description: Launch program to support the diagnosis, treatment, and prevention of neglected tropical diseases. More rapid regulatory pathways and efficient approaches to clinical trials using biomarkers will hasten the development of new drugs and diagnostics for preventing and treating neglected tropical diseases. Incentives to industry will be explored to stimulate product development for many diseases with unsatisfactory diagnosis, treatment and prevention options (e.g., Chagas disease, leishmaniasis, trypanosomiasis, filariasis). ORSI leads this project in coordination with CDER, CBER, and CDRH.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Create neglected/tropical disease working group

3/31/2010

Completed 3/15/2010

B. Hold Part 15 public meeting

9/22/2010

Completed 9/23/2010

C. Make recommendation to the Commissioner and draft report to Congress

3/31/2011

Completed 2/28/2011

D. Promote global collaboration to coordinate ongoing/future activities

6/30/2011

Completed 6/29/2011

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.