Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit electronic comments on FDA's objective to develop prioritized therapeutic area data standards or on the roadmap to
Traditionally, clinical study data submitted to FDA is in a format that is unique to each individual sponsor; furthermore the data quality varies. This has created inefficiencies in the review process and impeded efforts to analyze the data across applications when such analyses could be beneficial to detect trends in safety or efficacy or for other reasons. Sponsor adoption of available clinical trial data standards (CDISC/SDTM) for the submission of product applications have helped to improve the quality and standardization of submitted data. However, such a voluntary approach has proved insufficient to support both the current business requirements as well as efforts to modernize the review environment.
In 2011, the Center for Drug Evaluation and Research (CDER) identified a set of disease and therapeutic areas that could benefit from further standardization. These content area standards are primarily intended to support the efficient evaluation of medical products as noted previously in this document. Several factors were considered in the identification of these areas: (1) Areas of particular need, (2) areas with existing data standardization projects underway, and (3) areas with greater drug development pipeline activity. The initial prioritization was based on the number of active investigational new drug applications (or INDs) and input from review divisions, as well as from industry. The three tiers of priority were assembled into a roadmap and posted on the FDA Web site at
On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act of 2012, which includes the reauthorization of the Prescription Drug User Fee Act (PDUFA V). Under section XII of the PDUFA V performance goals, FDA agreed to create a plan for distinct therapeutic area data standards and to prioritize and develop the data standards in collaboration with CDISC and other open standards organizations. FDA is seeking public comment on the roadmap and will consider the comments as the Agency develops its proposed project plan which is due to be issued for review and comment by June 30, 2013. In addition, FDA will publish notices soliciting input on, and engagement in, standards development activities, and will periodically issue guidances specifying the completed data standards, formats, and terminologies that sponsors should use to submit data in applications.
Interested persons may submit either written comments regarding the roadmap, as well as recommendations on how the therapeutic area data standards development effort could be accomplished more rapidly, to the Division of Dockets Management (see
Persons with access to the Internet may obtain the roadmap at