About FDA
Updating Obsolete Regulatory Residue Methods Project
Description: Develop and validate better methods for veterinary drug residues. Perform bridging studies between the new and existing regulatory residue methods. This project will provide more rapid and reliable methods to detect unsafe veterinary drug residues in animal-derived food products. The improved methods will enhance regulatory agencies' ability to detect unsafe animal-derived food products. (1)
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
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1. Conduct method validation for: |
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a. Ceftiofur metabolite (marker residue) in ruminant tissues (with an emphasis on kidney, the target issue) |
5/31/2011 |
Completed | 5/31/2011 |
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b. Chlortetracycline in ruminant tissues (with an emphasis on kidney, the target issue) |
6/30/2011 |
Completed | 5/31/2011 |
|
c. Tetracycline in ruminant tissues (with an emphasis on kidney, the target issue) |
12/31/2011 |
Completed | |
|
2. Develop research protocol for ceftiofur: |
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a. Develop draft research protocol |
1/31/2011 |
Completed | 1/31/2011 |
|
b. Complete review and approval of research protocol |
3/15/2011 |
Completed | 3/15/2011 |
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3. Complete the pilot studies for: |
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|
a. Chlortetracycline |
5/3/2011 |
Completed | 4/29/2011 |
|
b. Ceftiofur |
7/31/2011 |
Completed | 7/31/2011 |
|
c. Tetracycline |
10/31/2011 (12/30/2011) |
Completed | 12/30/2011 |
|
4. Complete the main phases of the bridging studies for: |
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|
a. Chlortetracycline |
12/31/2011 |
Completed | 12/31/2011 |
|
b. Ceftiofur |
12/31/2011 (3/30/2012) (5/31/2012) |
Completed | 6/15/2012 |
|
c. Tetracycline |
4/30/2012 (7/31/2012) |
Completed | 6/15/2012 |
|
5. Complete assessment of research findings and reports |
6/30/2012 (12/30/2012) (1/31/2013) (5/30/2013) |
On Track | |
|
6. Determined the candidate drugs for future bridging studies |
6/30/2012 (12/30/2012) |
Completed | 12/3/2012 |
|
7. Submit methods paper manuscript for publication |
9/30/2012 |
Completed | 5/30/2012 |
Footnotes
- (1) The dates in italics under the milestone due dates are modified due dates which had to be updated due to real-time delays. The milestone status reflects the modified dates.
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
Ceftiofur
antimicrobial agent
Chlortetracycline
antimicrobial agent
Tetracycline
antimicrobial agent
protocol
guidelines
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.
