FDA meeting to address how to modernize its data strategy

By | January 10, 2020

The Food and Drug Administration is looking for public input on the agency’s efforts to modernize its data strategy, including approaches to quality, stewardship, exchange and analytics.

The FDA announced that it will conduct a public meeting on March 27 at the White Oak campus in Silver Spring, Md. According to the announcement, the agency intends to develop a modernized enterprise-wide strategic approach not only to technology—but to data itself.

“Data are the foundation of our most important work as a science-based regulatory agency—from reviewing medical products to identifying the source of a food-borne illness outbreak,” said FDA Commissioner Stephen Hahn, MD, in a written statement. “Because data are so essential to what we do, we are committed to ensuring that our mechanisms for collecting, reviewing and analyzing data are equally as sophisticated as the scientific advances that we are reviewing.”

In September, the FDA released a Technology Modernization Action Plan (TMAP) that lays out the agency’s short-term actions (12 to 24 months) to modernize its use of information technology, including computer hardware, software, cloud-based solutions and data exchange.

“Critical steps in transforming our computing and technology infrastructure are reflected in the FDA’s Technology Modernization Action Plan,” said FDA Principal Deputy Commissioner Amy Abernethy, MD. “This plan is an important step in closing the gap between scientific advances and the computing solutions needed to translate those advances into new therapies for patients. The next step is to combine our computing capability with state-of-the-art approaches in data management, analysis and decision-making.”

According to Abernethy, the purpose of the March 27 meeting is for public input and engagement on how the FDA can best approach important topics such as data stewardship, strategy and standards.

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The agency is starting to leverage real-world data gathered from electronic health records, lab tests, wearable devices, insurance claims and even social media to improve regulatory decisions regarding drugs and biologics.

“FDA needs to have a technical infrastructure that can accept, evaluate and analyze novel sources of data (e.g., real-world data) and apply that data to regulatory decision making,” according to the agency. “Building this infrastructure is a primary goal of the TMAP.”

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