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# CDER/CBER Plan on Data Standards
- URL: https://www.fdaweb.com/cder-cber-plan-on-data-standards/
- Published: 2018-02-05T12:00:00.000Z
- Updated: 2026-09-14T23:19:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140683

CDER and CBER have released their “[Data Standards Strategy FY2018-FY2022](https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM595163.pdf?ref=fdaweb.com)” that commits the Centers to continue the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the pre- and post-market regulatory review process. “Together the two Centers will leverage their combined resources, talent and expertise to maximize stakeholder collaboration, policy development, and project implementation to develop and use data standards for the effective and efficient review of pre- and post-market submissions of safety and efficacy data,” the document says. The Centers say that their data standards program is focused on three principles:

1\. Ensure the use of high quality data standards, by using voluntary and consensus-based standards development processes in accredited standards development organizations, in place of government-unique standards; unless such standards are inconsistent with law or otherwise impractical.

2\. Reduce the burden of regulation through alignment with existing health information technology initiatives, laws, regulations, and mandates such as executive orders.

3\. Ensure the effectiveness and broad utility of data standards through the adoption or adaptation of other standards currently in use, when feasible.