“… In September 2019, when we announced the U.S. Food and Drug Administration’s Technology Modernization Action Plan (TMAP) we spoke about the ways that the FDA is modernizing our approach to the use of technology for the agency’s regulatory mission, such as in the review of medical product applications and food safety, and other critical functions. Data modernization is the next step in the agency’s overhaul of its approach to technology and data, and we are pleased today to announce the Data Modernization Action Plan (DMAP).”
“Data have always formed the basis of the FDA’s science-based regulatory decision-making. These data may come from relatively traditional sources—for example, measurements submitted to the FDA from clinical trials or observations from FDA field inspections. As technology has become more sophisticated and our world has become more connected, data from many new sources are helping us understand how medical products are performing, how we can pinpoint the source of a foodborne illness, for example, or understand an emerging public health threat.”
Data Sources Are Increasingly Diverse
“Digitization of processes, pervasive use of mobile technologies, and easier access to computing resources have created new types of data. These data types and related technologies can be used to create innovative solutions to improve public health, such as:
- Capabilities to track and trace medical and food products can transform national response to emergencies by identifying product and logistic information across the entire supply chain.
- Integration of real-world and clinical trial evidence can increase representation of diverse populations. It can transform overall efficiency of product reviews and post market surveillance.
- Privacy sparing innovations can advance the evaluation of potential treatments for rare diseases while protecting patient specific information.”
“The new data strategy also calls for ways to scale agency work, such as the Advanced Semantic Search and Indexing of Text for Tobacco pilot to explore and build a model to scale search capabilities for complex tobacco submissions. Improved search capabilities based on context and intent will scale review, monitoring, and regulatory operations by reducing the burden of manual, inefficient processes on FDA staff.”
Delivering Value Through Driver Projects Will Inform Modernization
“The DMAP is anchored on driver projects that contribute to the FDA’s public health responsibilities in the near term while also building critical capabilities for the future. Driver projects for DMAP are defined as initiatives with measurable value that help multiple stakeholders envision what is possible, allow technical and data experts to identify needed solutions, and develop foundational capabilities. This strategy avoids the pitfalls of focusing on data collection first and only then looking for questions the data can answer…” Read the full article here.
Source: FDA’s Data Modernization Action Plan: Putting Data to Work for Public Health – By Janet Woodcock and Amy Abernethy, March 3, 2021. FDA.
