HealthIT Answers September 27, 2023
The U.S. Food and Drug Administration has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency’s technological advancement and the alignment with its broader public health mission. The IT Strategy fulfills commitments under the FDA’s Prescription Drug User Fee Act (PDUFA VII) reauthorization for fiscal years (FYs) 2023-2027 and obligations under section 3627 of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023. Led by the FDA’s Office of Digital Transformation with input from FDA centers and external stakeholders, the plan is both ambitious and collaborative, designed to meet the diverse needs of its internal and external constituents.
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