This post was written by Paul Sheives.

FDA is requesting comments on a draft document entitled ‘‘CDER Data Standards Plan Version 1.0,” which outlines the agency’s approach to establishing a comprehensive data standards program within the Center for Drug Evaluation and Research (CDER). Outlined in the plan are key objectives for a data standards program, processes to be developed to ensure successful use of those standardized data, and a set of recommended projects to begin in calendar year (CY) 2010. Written comments on the draft plan must be submitted by September 15, 2010.