FDA Launches Data Modernization Action Plan

The U.S. Food and Drug Administration (FDA) has launched its Data Modernization Action Plan to update how it handles and uses its large amount of health and safety data. Much of the agency’s data on drugs and medical devices is currently siloed and inaccessible. Improved data practices could allow for new approaches to regulation, rolling data sharing from companies submitting drugs and tools for review, and easier access to and analysis of existing documentation. One example of a project in progress under the plan will use artificial intelligence–based semantic search, which uses the contextual meaning of a search phrase and not only exact keywords, to pull out relevant files from the FDA’s trove of documents.

“As technology becomes more sophisticated and our world becomes more connected, data from many new sources can help us understand how medical products are performing, pinpoint the source of foodborne illness, or understand emerging public health threats,” the plan reads. “At the same time, FDA’s regulatory mission is growing more complex with the technological evolution of FDA-regulated products. New technologies hold enormous promise to patients and consumers – and unique challenges for responsible regulation. Without modern expertise and approaches to managing and analyzing data, FDA will miss critical opportunities to benefit patients and improve public health.”

The Data Modernization Action Plan has three objectives:

  1. Identify and execute high value driver projects for individual centers and for the agency
  2. Develop consistent and repeatable data practices across the agency
  3. Create and sustain a strong talent network combining internal strengths with key external partnerships

Previously, in September 2019, the FDA published the Technology Modernization Action Plan to modernize the agency’s technical infrastructure as a foundation for these planned improvements to data management.

Sources: STAT, March 4, 2021; FDA report, March 3, 2021.