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U.S. Department of Health and Human Services

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 DescriptionMilestone DateMilestone StatusMilestone 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 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.