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# Woodcock Outlines IT Transformation at FDA
- URL: https://www.fdaweb.com/woodcock-outlines-it-transformation-at-fda/
- Published: 2022-08-04T12:00:00.000Z
- Updated: 2026-09-14T17:54:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152450

After decades of high-level neglect, FDA is at last modernizing its multiple, decentralized information technology (IT) systems. Principal deputy commissioner **Janet Woodcock** 8/4 told an Alliance for a Stronger FDA Webcast that the agency is now working toward transformational new efficiencies through an FDA-wide enterprise approach to its business process, data, and technology management that will allow it to optimize the use of the vast amounts of data that are the foundation of its work.

FDA spends about a $1 billion annually on information processing and its information needs are not being met, Woodcock said. “We have to do a lot of manual processing. And we also eventually rely upon informal networks to exchange important information because we don't have systems to do that… We don’t have, for example, a single workflow management system for regulatory agencies that need cross agency processes, for example inspections… We don’t have a single source data set for things like firms and establishments,” which she said is a problem for regulating imports.

The majority of the agency’s systems were developed in-house and customized, and most are not interoperable with other systems, even those in the same Center, according to Woodcock. “So we have to write programs and write code and so forth or do other maneuvers to gather information from the various systems,” she explained. “There’s a real absence of data standards and change control and much of the information and data have to be manually searched. I call this our archaeological expeditions that we have to go on because the data are not in a condition to be accessed automatically and generate analyses.” Much of the supporting software is old and at “end-of-life,” Woodcock said, and so FDA’s IT people are maintaining these systems to adhere to cybersecurity standards and to make sure they continue to operate, which is a drain on resources, she said.

The lack of a centralized data management system also contributes to poor knowledge management. “We continue to get external complaints about inconsistency in our regulatory decisions,” Woodcock told the Alliance. “But if we can’t keep those in a place where they’re accessible, staff may not even be aware of the prior decision and how it was made, and what the consequences were.” She said the inadequate systems also have a big impact on the actual effectiveness of the agency’s regulatory programs, “because the right staff at the right time may not have access to the data that would be critical to making the correct decision. And this of course, is the thing that concerns me very greatly about our current situation, for example our import screening may rely on incomplete data sources.”

Additionally, Woodcock said the agency has very fragmented process management. So with inspections, the “processes are not connected across the product programs in the field, and so there are manual hand-offs of inspection requests and then inspection results coming back,” she said. Freedom of Information Act requests are equally troublesome, with at least four different IT platforms in use for these in the centers. This has led to backlogs across the agency, she said.

Woodcock said the Office of the Commissioner has requested a reorganization program to house an enterprise transformation group under her leadership. One of the first ongoing projects to come from this is an inspection process optimization pilot “because ordering up and executing and then evaluating the results of an inspection are some of the core activities that we do at the enterprise level,” Woodcock said.

The inspection pilot is operating in CDER and CFSAN, and it is using inspection protocols that will have standardized data elements. “So we will then have data from the inspections rather than a prose report, and we'll be able to perform analyses on that,” Woodcock said. It also uses a single workflow management platform to move the inspection requests from the center to ORA and back. Another pilot is working on master data management for an inventory of firms, such as where establishments are located and identifying what they manufacture.

All of these changes require increased funding, which is being sought in the 2023 and 2024 budget requests, Woodcock said. Work is underway to develop a modern information technology organization, such as developing an infrastructure library and a next-generation data center. New applications that are developed are being installed on the cloud, and FDA has been increasing its use of machine learning and artificial intelligence for supply chain issues. And more work continues to be directed at the agency’s cybersecurity program “because we continue to have many attempts at breaching our firewalls,” she said.