FDA seeks input on boosting data and technology capabilities
The US Food and Drug Administration (FDA) is requesting stakeholder input on how it can advance its data and technology capabilities under the data modernization framework. These responses will be used to “define and shape” its data and technology strategic plan covering fiscal years 2024 to 2027.According to a notice published in the Federal Register on Wednesday, the plan fulfills a commitment made in the Prescription Drug User Fee Act (PDUFA VII) agreement for fiscal years 2023-2027 as well as a requirement of the recent omnibus spending bill (RELATED: Omnibus spending bill would give FDA a $102M boost for FY2022, Regulatory Focus 9 March 2022)
“This plan will define and shape the future course of FDA’s data and technology capabilities, building on the existing FDA Modernization Framework,” the agency announced. The plan must be published by 30 September 2023.
The agency’s modernization framework, developed by the recently established Office of Digital Transformation (ODT), includes the Technology Modernization Action Plan (TMAP), the Data Modernization Action Plan (DMAP), and the Leadership Modernization Action Plan (LMAP). The TMAP, announced in September 2019, aims to beef up the agency’s hardware and software technologies to better accommodate novel sources of data, such as real-world data. (RELATED: FDA Lays Out Tech Modernization Action Plan, Regulatory Focus 18 September 2019)
The data modernization plan was unveiled in March 2021. (RELATED: FDA unveils data modernization plan, Regulatory Focus, 3 March 2021)
FDA said the new Data and Technology Strategic Plan will build on the modernization framework. The agency also said it will take an iterative approach in developing the plan by first collecting public input, releasing a draft version for comment, and publishing a final version after considering any feedback it receives. “Stakeholder input is crucial for developing a comprehensive plan that best meets the needs and goals of industry and the agency,” said FDA.
The agency said it wants input in several specific areas, including what outcomes stakeholders think the plan can help them achieve; challenges stakeholders face in achieving those outcomes; and areas in which FDA could strengthen its data and technical capabilities. Input is also being sought on potential opportunities and risks the agency could face with its plan; industry changes and trends that could affect the plan; and how the agency can best communicate and engage with stakeholders.
Stakeholders will have 30 days to comment.
FDA’s data and technology strategic plan
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