CDER, CBER Outline Data Standards Strategy Through 2022

Regulatory NewsRegulatory News | 05 February 2018 |  By 

The US Food and Drug Administration's (FDA) drugs and biologics centers on Monday released their shared strategy for selecting, developing and implementing data standards over the next five years.

Specifically, the strategy outlines the governance framework and goals for using data standards for the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

"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 postmarket submissions of safety and efficacy data," FDA writes.

FDA also says the data standards strategy is in line with its other major strategic initiatives, such as its Strategic Policy Roadmap and Information Technology Strategic Plan, as well as the 21st Century Cures Act and the its commitments under the recently reauthorized Prescription Drug User Fee Act (PDUFA VI).

According to FDA, the data standards strategy will operate based on three main principles, including favoring consensus-based standards over "government-unique standards" where possible; reducing the regulatory burden by aligning data standards with existing initiatives, laws and regulation; and using or adapting existing data standards when feasible.

FDA also lays out six goals it hopes to achieve through its data standards strategy:

  • Goal 1: Incorporate data standards to support more efficient, science-based pre-market review of medical products.
  • Goal 2: Improve the post-market risk management strategies and pharmacovigilance and surveillance of medical products by using data standards.
  • Goal 3: Implement common data standards to improve the quality and integrity of marketed medical products.
  • Goal 4: Promote innovation in the development and use of data standards.
  • Goal 5: Ensure effective communication and collaboration with stakeholders on data standards.
  • Goal 6: Improve the management and usability of the volume of information through data standards

By using common data standards, FDA says it hopes to be able to make the information it gathers from drugmakers more useful.

"Standardized data elements and relationships, for example, that are important to a disease or therapeutic area are essential so that data from multiple trials can be more easily grouped for analysis and reporting, as well as for meta-analyses within and across medical product classes," FDA writes.



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