Data are a critical resource for all of FDA’s work. Unleashing the power of data refers to identifying and using reliable data sources, some of which may represent large, complex data sets requiring improved analytics, and in some cases, harnessing high-performance computing environments and new computational tools based on artificial intelligence (AI). FDA is working to obtain more and higher-quality data, be more proactive in gathering data, be more creative in analysis and interpretation, to support regulatory decision making in different aspects of the lifecycle of regulated products.
The healthcare system generates an abundance of clinical care data that can potentially be harnessed to inform regulatory decision making. These health data include but are not limited to data from electronic health records (EHRs), medical imaging, genomic sequencing, pharmacy dispensing, payor records, pharmaceutical research, digital health technologies (DHTs), and medical devices.
The breadth, depth, and diversity of these data can help fill knowledge gaps related to product safety, effectiveness, and risk reduction. Insights gained from data are balanced with subject matter expertise to make decisions and draw conclusions, especially when unique data features and potential limitations may give rise to misinterpretations and conflicting conclusions in clinical studies.
FDA uses healthcare data and analytics to improve the quality and integrity of FDA-regulated products throughout the product lifecycle. Rapid collection and analysis of quality data can help fill knowledge gaps and inform FDA regulatory decision-making. FDA is interested in developing new approaches to harnessing these data to improve regulatory decision-making and more effectively connect today’s groundbreaking scientific discoveries with the rapid development and review of new FDA-regulated products. FDA can also increase the knowledge of patients and consumers who must make informed decisions about FDA-regulated products.
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