The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have released their shared data standards strategy for fiscal years 2018–2022.

The purpose of the CBER–CDER Data Standards Strategy is for the development, implementation, and maintenance of a 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 FDA said in the January 2018 strategy document.

This strategy is aligned with several FDA plans, which include the following: the FDA Strategic Policy Roadmap, which highlights the agency’s priorities; the FDA Information Technology Strategic Plan, made to ensure alignment between FDA’s strategic objectives and its strategic information technology (IT) initiatives; CBER’s Interim Strategic Plan; CDER’s Strategic Plan; The 21st Century Cures Act, a law signed in December 2016  help accelerate medical product development and bring new innovations; and the commitments under Prescription Drug User Fee Act (PDUFA) VI, the branded drug user-fee program.

The FDA says its data-standards program is focused on three principles:

• 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;
• Reduce the burden of regulation through alignment with existing health information technology initiatives, laws, regulations, and mandates, such as executive orders; and
• Ensure the effectiveness and broad utility of data standards through the adoption or adaptation of other standards currently in use, when feasible.

The CBER–CDER data standards have six goals, which focus on key areas that are expected to help improve the exchange, review, and management of medical product data. The goals are outlined below.

• 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.

The FDA says it expects common data standards to provide new opportunities to transform data generated in regulatory submissions into useful information to potentially speed the delivery of new therapies to patients. “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,” the FDA said in the strategy document.

Source: FDA