FDA's “All-in” Approach to Enterprise Transformation

The U.S. Food and Drug Administration's responsibilities to protect the public health are broad, complex, and necessary because the products we regulate are in every home and used every day across the U.S. As we witnessed during the pandemic, the FDA plays a critical role in enabling access to safe and effective medical products, such as vaccines, therapeutics, and accurate diagnostic testing. The agency also monitors and supports the supply chains for critical components of these products, while continuing to ensure the safety of our food supply, all in an increasingly complex and interconnected environment.

In meeting our public health mission, the FDA must have more effective and efficient business processes, increased capabilities to better use the data that we review, and a more coordinated development of the IT systems designed to support these activities. In the past, the FDA has taken an organization-based approach to process development and IT investments, resulting in siloed solutions and a fragmented data environment. To achieve new efficiencies, the FDA is advancing an agency-wide enterprise approach to business process, data, and technology management that will allow us to work more efficiently and optimize the use of the vast amount of data that is the foundation of our work.

Today we are introducing the Enterprise Modernization Action Plan, which is the next phase of the FDA’s stronger data and technology foundational approach.

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