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  1. Electronic Regulatory Submission and Review

Priority Therapeutic Areas for Development

Standardizing key study data specific to therapeutic areas (TAs) will facilitate clinical research and the evaluation of medical products.  In 2011, CDER identified a set of therapeutic areas that could benefit from further standardization, organizing them into three tiers of priority. Several factors were considered at the time: (1) areas of particular medical need, (2) areas with existing data standardization projects underway, and (3) areas with greater drug development pipeline activity.  The number and ordering of these areas may change as stakeholder input and further analyses are considered. 

The roadmap below displays the TAs in priority groupings and suggests a series of standardization projects over time to achieve significant results by December 2017. This roadmap assumes standardization projects for therapeutic areas are scoped narrowly enough to be accomplishable within a 12-month period, and that subsequent projects in those areas build on the results. Periodically, updates to the timeline will be provided as progress, opportunity and additional information is available. The tabular version, also listed below, provides the current status information for all identified TAs. 

FDA, CDISC, and the Critical Path Institute are collaborating on efforts to support development of therapeutic area standards.  FDA is also collaborating with HL7’s Clinical Interoperability Council and other consortia to define related clinical concepts.  We encourage stakeholders to engage in and, where possible, support these data standardization efforts.

Questions and comments can be forwarded to [email protected].

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