About FDA
Use of portable scientific applications to assist in regulatory decisions earlier in the supply chain
Description: Identify and develop analytical tests, test applications, special techniques and laboratory space to deploy outside of the traditional laboratory sites in order to provide an assessment of the compliance status of a product or process in an expedited manner.
Briefing Status: On Track
Prior Briefing Status: On Track
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Develop/identify analytical tools and techniques for forward deployment to the field to focus on sampling activities |
N/A |
Completed | 1/1/2010 |
|
2. Validate and qualify X-Ray Fluorescence device (XRF). (XRF is a handheld device used to detect low level elements in food and drug products.) |
N/A |
Completed | 3/26/2010 |
|
a. Establish requirements for deployment to the field of XRF |
5/31/2010 |
Completed | 5/31/2010 |
|
b. Conduct training and issue XRF of investigators on use of XRF |
7/15/2010 |
Completed | 7/15/2010 |
|
c. Issue XRF assignment to the field |
9/1/2010 |
Completed | 9/1/2010 |
|
d. Assess results of XRF assignment, field feedback and analytical findings for determination of possible modifications |
11/1/2010 |
Completed | 2/4/2011 |
|
3. Validate and qualify Ion Mobility Spectroscopy device (IMS). (IMS is a handheld device technology based on molecular mass used to analyze herbal and "natural" products for the presence of sibutramine and fluoxetine.) |
N/A |
Completed | 3/26/2010 |
|
a. Establish requirements for deployment to the field of IMS |
9/30/2010 |
Completed | 9/30/2010 |
|
b. Conduct training and issue IMS of investigators on use of IMS |
11/15/2010 |
Completed | 12/15/2010 |
|
c. Issue IMS assignment to the field |
1/1/2011 |
Completed | 2/11/2011 |
|
d. Assess results of IMS assignment, field feedback and analytical findings for determination of possible modifications |
3/1/2011 11/1/2011 9/28/2012 2/28/2013 |
On Track | |
|
4. Validate and qualify Raman. (Raman is a handheld device technology based on unique symmetrical atomic bond vibrations used to detect diethylene glycol (DEG) in glycerin and ethylene glycol (EG) in sorbitol.) |
N/A |
Completed | 3/26/2010 |
|
a. Establish requirements for deployment to the field of Raman |
1/31/2011 |
Completed | 3/25/2011 |
|
b. Conduct training and issue Raman to investigators |
3/15/2011 |
Completed | 9/10/2011 |
|
c. Issue Raman assignment to the field |
6/1/2011 |
Completed | 9/19/2011 |
|
d. Assess results of Raman assignment, field feedback and analytical findings for determination of possible modifications |
8/1/2011 1/15/2012 11/1/2012 4/30/2013 |
On Track | |
|
5. Validate and qualify Near InfraRed Spectroscopy device (NIR). (NIR is a handheld device technology based on unique asymmetrical atomic bond vibrations used to detect diethylene glycol (DEG) in propylene glycol and melamine in lactose.) |
N/A |
Completed | 3/26/2010 |
|
a. Establish requirements for deployment to the field of NIR |
6/30/2011 |
Completed | 9/2/2011 |
|
b. Conduct training and issue NIR to investigators |
8/15/2011 10/24-11/10/2011 |
Completed | 2/10/2012 |
|
c. NIR assignment to the field |
10/1/2011 11/7/2011 |
Completed | 5/30/2012 |
|
d. Assess results of NIR assignment, field feedback and analytical findings for determination of possible modifications |
12/1/2011 2/20/2012 10/1/2012 6/30/2013 |
On Track | |
|
6. Deploy mobile laboratories to growing, harvesting, processing and manufacturing sites for expedited analysis of samples |
9/30/2010 |
Completed | 9/30/2010 |
|
7. Identify critical border sites for establishment of satellite laboratories |
9/30/2010 |
Completed | 9/30/2010 |
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.
