The Food and Drug Administration (FDA) is seeking public comments to accompany the following public meeting entitled “Modernizing FDA's Data Strategy.” The purpose of the public meeting and the request for comments is to discuss possible Agency level approaches to modernizing FDA's data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics.
FDA is gathering scientific and technical information to help inform its development of an Agency-wide, strategic approach to modernizing its data strategy, including data quality, data stewardship, data exchange, and data analytics. The Agency has determined that a public meeting and an open public docket will encourage public input and engagement in this important topic.
In September 2019, FDA announced its Technology Modernization Action Plan (TMAP). The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data, and analytics—to advance FDA's public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is responsive to novel technologies and rapidly increasing workloads.
To achieve these goals, FDA intends to develop a modernized Agency-wide, strategic approach not only to technology, but to data itself. Data is at the heart of FDA's work as a science-based Agency, and we anticipate ongoing, rapid increases in the amount and complexity of the data that informs FDA's regulatory decision-making process and how we advance our public health mission.
The Agency welcomes any relevant scientific and technical information related to FDA's consideration of the following topics:
- 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 health care 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?
Members of the public may submit comments online at Regulations.gov, or via mail. For more information on the meeting, please see this Federal Register notice or this FDA website.