On January 7, 2020, the US Food and Drug Administration (FDA) announced that it will hold a public meeting on March 27 to discuss possible Agency-level approaches to modernizing FDA’s data strategy, including approaches to data quality, data stewardship, data exchange and data analytics. Topics for discussion during the public meeting—and in written comments submitted to the parallel public docket—include the following:

Standards and policy, including:

• How can FDA best use policy and common data standards to help ensure the effective and efficient use of data assets?

• What are the consequences/issues as we move from ”static point-in-time data sets” to updating digital data streams for analyses?

• As we move into increased sharing and integrated data sets, how might FDA manage data in a way that avoids unnecessary duplication?

Data security, privacy and management including:

• How can FDA modernize its data strategy to continue ensuring privacy and security of data?

• What should FDA do to promote the management and organization of data assets across the Agency, as the amount and complexity of data (e.g., in regulatory submissions to FDA) is rapidly increasing?

Data strategies and data sharing, including:

• How can FDA’s data strategy facilitate broader goals of integration and interoperability of healthcare data, and scientific data/virtual patient data generated using scientific models?

• How can FDA design its data strategy to reflect a global marketplace and promote clarity to data providers like regulated industry and other stakeholders?

• How can FDA design its data strategy and policy development to facilitate appropriate data access, data sharing within the Agency and via data sharing agreements, as well as the appropriate reuse and repurposing of data to advance Agency regulatory science priorities?

• For stakeholders, including regulated industry, that submit data to FDA, how can FDA enhance the efficiency of the preparation and submission of data to FDA?

Individuals interested in presenting at and/or participating in a panel at the meeting should apply to do so by providing the information described in the Federal Register by January 28, 2020. Stakeholders who only wish to attend the public meeting in person must register by March 24, 2020. Lastly, stakeholders who intend to provide written feedback on this topic should submit written comments to the public docket by April 30, 2020.

Implications

The public meeting and docket represent the agency’s latest effort to deal with the rapid, ongoing uptick in the amount and complexity of data that increasingly informs regulatory decision-making. Interested stakeholders should take advantage of this opportunity to provide the agency with meaningful input on how best to update its existing data strategy.