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  1. Electronic Regulatory Submission and Review

Data Standards Program Strategic Plan and Board

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Strategic Plan

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

The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.

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).

When standards are adopted or retired, FDA will follow the process outlined in the Providing Regulatory Submissions In Electronic Format – Standardized Study Data Guidance for Industry. This Guidance outlines that FDA may announce the future availability of new standards and version updates to existing standards through Federal Register notices. The FDA Data Standards Catalog (located on the Study Data Resources page) is updated when that occurs.

Current Program Documents

Archived Program Documents

Data Standards Program Board

The CDER Data Standards Program Board coordinates data standards activities within CDER and with other Centers and stakeholders. The Board has representatives from offices across CDER, CBER, and the Center for Devices and Radiological Health. The Board oversees the execution of the CDER Data Standards Strategy and Program Action Plan and the ongoing planning, coordination, and progress-tracking of data standards projects.