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 Description | Milestone Date | Milestone Status | Milestone 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 Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - 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.
