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U.S. Department of Health and Human Services

About FDA

Tuberculosis Initiative

Description: Facilitate the development of medical products, including vaccines, for the diagnosis, prevention, and treatment of tuberculosis (TB), including resistant TB. This will hasten development of new drugs for drug-resistant and drug-sensitive TB, and may facilitate shortening of therapy. It will provide the public with new diagnostic tests to determine durable cure in TB, to identify drug resistance early and expedite appropriate therapy, and to diagnose TB in children. The office leads this project in coordination with CDER, CBER, and CDRH.

Accomplishment: Critical Path's June 7, 2010 TB Diagnostic Workshop drew more than 150 participants from around the world. Consensus was reached on priority areas for research. The meeting report Advancing the development of diagnostic tests and biomarkers for tuberculosis was co-authored by FDA experts and published in the International Journal of Tuberculosis and Lung Disease (IJTLD). An RFA was published with numerous responses. A review committee comprising members within and outside FDA awarded funding to six applicants on September 22, 2010. A grant-holder meeting was held at FDA on March 29, 2011, at which scientific presentations were given to a broad FDA audience, and areas for collaboration between the programs were identified. As a result, progress reports from the awardees are being evaluated to determine ongoing funding.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Create FDA TB working group

3/31/2010

Completed 3/15/2010

B. Plan and conduct a workshop on developing TB diagnostics, with broad participation from U.S. government agencies, and local and international stakeholders in TB diagnostic development

6/30/2010

Completed 6/7/2010-6/8/2010

C. Develop content and issue Request for Applications addressing appropriations language

7/1/2010

Completed 7/14/2010

D. Establish committee and procedure for review of applications/award grants

7/30/2010

Completed 9/10/2010

E. Make awards

9/30/2010

Completed 9/22/2010

F. Hold Awardee meeting to share progress and facilitate collaboration

3/31/2011

Completed 3/29/2011

G. Identify collaborative expansion of TB awards program

9/30/2011

Completed 3/29/2011

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.