MainAn End-of-Phase 2A (EOP2A) meeting provides an additional opportunity for in-depth, exploratory discussion with FDA focused on optimizing next steps in drug development. The goal of earlier discussions is to avoid pitfalls in dose selection and clinical trial design that could result in subsequent safety issues due to selecting doses that are too high, in efficacy issues due to selecting doses that are too low, or in unnecessary clinical trial failure from not accounting for disease natural history, inappropriate patient selection, effects in the placebo group, or dropouts. An EOP2A meeting would occur after the completion of clinical trials that provide data on the relationship of dosing and response for the particular intended use (including trials on the impact of dose ranging on safety, biomarkers, and proof of concept). These meetings listed (e.g., EOP2A, VXDS, biomarker qualification) are intended to improve drug development process and reduce attrition rate caused by poor dose selection and study design. <br>This measure has been retired as CDER has created new measures 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> Number0

Oct 20093Nov 20090Dec 20090Jan 20101Feb 20100Mar 20101Apr 20100May 20100Jun 20103Jul 20101Aug 20100Sep 201010

FY 2011 Total: 11

Oct 20101Nov 20101Dec 20101Jan 20110Feb 20110Mar 20111Apr 20110May 20110Jun 20113Jul 20112Aug 20111Sep 201110

FY 2012 YTD: 1

Oct 20110Nov 20111Dec 20110Jan 2012Feb 2012Mar 2012Apr 2012May 2012Jun 2012Jul 2012Aug 2012Sep 2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard