Stay Connected with CDER
Send your questions or comments to CDER Data Standards team at:
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
- CDER Data Standards Program 2018 Annual Assessment
- CBER-CDER Data Standards Strategy FY2018-2022
- Data Standards Program Action Plan v4.0
- Data Standards Communications Plan v1.5
Archived Program Documents
- CDER Data Standards Program 2017 Annual Assessment
- Data Standards Program Action Plan v3.7
- Data Standards Program Action Plan v3.6
- Data Standards Program Action Plan v3.5
- Data Standards Program Action Plan v3.4
- Data Standards Program Action Plan v3.3
- Data Standards Program Action Plan v3.2
- Data Standards Program Action Plan, Version 3.0
- Data Standards Strategy
- Data Standards Strategy
- CDER Data Standards Program 2016 Annual Assessement
- Data Standards Program Action Plan v3.1
- CDER Data Standards v1.4
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.
- CDER Data Standards Program Board Charter (PDF - 56KB)
- CDER Data Standards Program Board Membership (PDF - 111KB)