Present the revised Compliance Program for PreApproval Inspections/Investigations to industry groups in order to clarify to regulated firms FDA's procedures for assigning, performing, and evaluating inspections associated with new drug or generic drug approvals.The<a href= http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/default.htm target=”_blank> Compliance Program Guidance Manual</a> compiles the agency’s internal programmatic directives between the Center compliance offices and the Field investigators, analysts, and compliance officers. By publishing CPs on www.fda.gov10 FDA provides an unprecedented degree of transparency for a regulatory agency. The CDER Office of Compliance will ‘roll out’ a revised or new CP to industry groups to maintain transparency and improve communications. The update of the PreApproval Inspections/ Investigations CP11 will be presented to industry groups with the goal of improving New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) information, explaining selection of manufacturing site inspections, and improving industry understanding of the Program.Completed1. Complete CDER and Office of Regulatory Affairs (ORA) final approval of CP 7346.8324/16/2010Completed4/7/20102. Submit accessible CP document for posting on Inside.FDA and www.fda.gov4/23/2010Completed4/12/20103. Outreach plan and tools drafted and approved6/30/2010Completed7/14/20104. Complete at least two outreach activities12/21/2010Completed9/13/2010http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard