Assessment of histopathology practices in biomarker qualificationThis project will adopt modern tissue imaging methods to the quantification of drug-induced injury to specific organs in appropriate animal models (e.g. incipient pancreas injury in Sprague-Dawley rats exposed to low doses of anti-diabetic drugs).<br>This key project 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. </b>
ON HOLDON HOLD1. Develop concept paper3/31/2010Completed3/31/20102. Finalize research plan4/15/2010Completed4/15/20103. Submit protocol4/22/2010Completed4/22/20104. Initiate study5/1/2010Completed5/1/20105. Conduct interim analysis7/15/2010Completed7/15/20106. Complete study (1)9/30/2010 <i>(4/30/2012)</i>Not Yet Started7. Release study report (1)12/31/2010 <i>(7/31/2012)</i>Not Yet Started(1) The dates in italics under the milestone due dates are revised milestone due dates which have been updated.