Compliance Program (CP) Updates-ImplementationImplement the new compliance program for drug process inspections of Positron Emission Tomography (PET) drugsThis 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.
Not Yet StartedNot Yet StartedMain1. Public publication of CP 7356.002P on FDA website10/1/2011Completed10/27/2011Main2. Internal FDA training on new CP11/1/2011 <i>12/12/2011</i>On TrackMain3. Submit and confirm reallocation of inspectional resources to increase PET inspections above FY 11 levels12/1/2011On TrackMain4. Monitor inspectional activity and findings9/30/2012Not Yet StartedMain5. Complete at least 1 outreach activity9/30/2012Not Yet StartedMain6. Evaluate PET website and recommend improvements to CDER ORP based on program monitoring9/30/2012Not Yet Started