Drugs

CDER Data Standards Program

The CDER Data Standards Program established in 2010 is a comprehensive program within the Center to identify and prioritize data standards needs and to implement good practices for standards development. Where current standard specifications are not available or not adequate, CDER plans to engage appropriate Standards Development Organizations (SDOs), as well as industry and other stakeholders, to take full advantage of the capabilities offered by the formal SDO processes. The CDER Data Standards Program Board coordinates data standards activities within CDER and with other Centers and stakeholders. The Board oversees CDER Data Standards Strategy and Program Action Plan execution and the ongoing planning, coordination and progress-tracking of data standards projects.  

The Data Standards Strategy reinforces CDER’s on-going commitment to the development, implementation and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions such that safe and effective products are available to the market sooner. The Data Standards Plan (Version 1.1) issued in December 2010 is superseded by the Strategy and the Data Standards Program Action Plan.

The scope of this Strategy is limited to the identification of need, development, implementation and maintenance of data standards required for the efficient and effective review of sponsor submissions by CDER. It is aligned with the goals and objectives of the FDA’s Strategic Plan,   and the performance goals of the PDUFA V Reauthorization as captured in the FDA Safety and Innovation Act (FDASIA).

CDER’s approach to data standards consists of four strategic goals:

  • Support open, consensus-based data standards development

  • Maintain and promote a well-defined data standards governance function
  • Promote the electronic submission of regulatory data using established standards
  • Optimize the regulatory review process to fully leverage data conformed to standards

Questions or comments should be forwarded to the CDER Data Standards team at CDERDataStandards@fda.hhs.gov.

 

Therapeutic Areas Standards Development

Page Last Updated: 08/29/2014
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