FDA PDUFA Reauthorization Looks to Increase Use of Decentralized Trial Technology

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The U.S. Food and Drug Administration (FDA) affirmed its commitment to leveraging new technologies and promoting aspects of decentralized clinical trials (DCTs) in its Prescription Drug User Fee Act (PDUFA VII) commitment letter released on August 23.

Among other promises, FDA said it will follow a Data and Technology Modernization Strategy for current and future data-driven regulatory initiatives. FDA will establish a strategy that reflects the vision in FDA’s Technology and Data Modernization Action Plans, including: outlining key areas of focus and approach including leveraging cloud technologies to support applicant-FDA regulatory interaction; articulating enterprise-wide approaches for both technology and data governance; and aligning strategic initiatives in support of PDUFA review goals, drawing a line of sight between initiatives and the enterprise strategy (i.e., the agency-wide strategy also supporting components outside PDUFA).

The strategy will be shared and annually updated to reflect progress and any needed adjustments. Milestones and metrics for PDUFA initiatives will be included in the updates.

FDA also said it would accelerate modernization of its Center for Biologics Evaluation and Research (CBER) during PDUFA VII. CBER will retire its older information technology (IT) systems and capabilities, leverage capabilities in other FDA centers where feasible, and utilize new data management tools and technologies in line with agency strategic plans and effective use of resources.

In coordination with the Centers for Drug Evaluation and Research and for Devices and Radiological Health, CBER will accelerate its data and IT modernization in order to leverage or develop state-of-the-art IT technology to provide cloud-based, agile, and stable integrated platforms; streamline and improve its ability to perform complex reviews to access, utilize, and protect data; and redirect IT spending from maintenance of older IT systems to improving the reviewer experience. Modernization efforts will enable new capabilities such as knowledge management, data and analytic reporting, decision tools, and workflow and workload management to be developed sooner, FDA said.

FDA will also hold a public meeting September 28, 2021 to hear comments on the PDUFA reauthorization.

Edited by Michael Causey