Total number of industry meetings that OCP leads related to for example, guidances, End-of-Phase 2A (EOP2A) requests, EOP2 meetings, Voluntary Exploratory Data Submission (VXDS) and biomarkers meetings attended per month
Dictionary: An 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.
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.
Fiscal Year - 2010
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.