About FDA
Compliance Program (CP) Updates-Implementation
Description: Implement the new compliance program for drug process inspections of Positron Emission Tomography (PET) drugs
This key projects has been retired as CDER has created new measures and key projects for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.
Briefing Status: Not Yet Started
Prior Briefing Status: Not Yet Started
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Public publication of CP 7356.002P on FDA website |
10/1/2011 |
Completed | 10/27/2011 |
|
2. Internal FDA training on new CP |
11/1/2011 12/12/2011 |
On Track | |
|
3. Submit and confirm reallocation of inspectional resources to increase PET inspections above FY 11 levels |
12/1/2011 |
On Track | |
|
4. Monitor inspectional activity and findings |
9/30/2012 |
Not Yet Started | |
|
5. Complete at least 1 outreach activity |
9/30/2012 |
Not Yet Started | |
|
6. Evaluate PET website and recommend improvements to CDER ORP based on program monitoring |
9/30/2012 |
Not Yet Started |
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.
