FDA continues data modernization with new Office of Digital Transformation

Regulatory NewsRegulatory News | 16 September 2021 |  By 

The US Food and Drug Administration (FDA) is moving forward in plans to modernize its data and information technology efforts with the launch of a new Office of Digital Transformation (ODT).
“Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said acting FDA commissioner Janet Woodcock, in a Wednesday press release announcing the newest step in its technology modernization plan.
“The agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of what we do,” added Woodcock. FDA took its first modernization steps in 2019 with the launch of its technology modernization action plan, which began to bring FDA’s submission review process up to date, among other modernization steps. (RELATED: FDA lays out tech modernization action planRegulatory Focus 18 September 2019)
FDA then began implementation of the data modernization action plan in early 2021; this next phase is focused on efforts to “identify and execute high value driver projects for individual centers and for the agency,” according to the press release. ODT will have an agency-wide perspective and provide leadership on IT, data and cybersecurity issues at the enterprise level, according to the new office’s website. (RELATED: FDA unveils data modernization plan, Regulatory Focus 3 March 2021)
One ODT focus will be to reduce redundancy within FDA by integrating and streamlining data and IT processes when feasible by such means as encouraging the use of shared services and a more consistent approach to data management. The goals of the agency’s data modernization plan will be advanced through the use of “driver projects” that meet current FDA needs and goals but also build future capabilities.
FDA also acknowledges that IT and data talent acquisition and management are challenging, so successful modernization will also include crafting a compensation plan that can attract and retain data and computer scientists.
Vid Desai was appointed FDA’s chief information officer and head of ODT. Desai had previously held chief information officer roles at several medical device firms before joining FDA in 20  as the agency’s chief technology officer in mid-2019.
“This reorganization strengthens our commitment to protecting and promoting public health by improving our regulatory processes with a solid data foundation built in at every level,” said Woodcock.
FDA ODT press release


© 2023 Regulatory Affairs Professionals Society.

Tags: data science, FDA, IT, US

Discover more of what matters to you