Each year, CDER receives more than 300,000 submissions, amounting to millions of pieces of data. CDER reviews the data to bring lifesaving new drugs to market while protecting public health. The data can arrive in a wide variety of formats and even on paper, complicating the review process. To help simplify the process, more than a decade ago, FDA began requiring that certain submissions meet data standards.
The CDER Data Standards Program does the following:
- Identifies data standards needs
- Determines priorities for these needs
- Works with organizations that develop standards, industry, and other stakeholders to find or develop the necessary standards
Where current standard specifications are unavailable or inadequate, CDER plans to engage appropriate Standards Development Organizations (SDOs), as well as industry and other stakeholders, to develop new standards through SDO processes.
Learn more about the Data Standards Program Strategic Plan and Board.
