About FDA

Launched in collaboration with the U.S. Department of Health and Human Services’ Innovation, Design, Entrepreneurship and Action (IDEA) Lab, Information Exchange and Data Transformation (INFORMED) is an incubator for collaborative oncology regulatory science research focused on supporting innovations that enhance FDA’s mission of promotion and protection of the public health.

The challenge

How might we help the Food and Drug Administration actively pursue the development of programs to support creation of a knowledgeable, sustainable, and agile data science workforce?

Launched in collaboration with the U.S. Department of Health and Human Services’ Innovation, Design, Entrepreneurship and Action (IDEA) Lab, Information Exchange and Data Transformation (INFORMED), is an incubator for collaborative regulatory science research focused on supporting innovations that enhance FDA’s mission of promotion and protection of the public health. Drawing from the expertise of a diverse group of oncologists, data scientists, statisticians, and entrepreneurs-in-residence, INFORMED is expanding organizational and technical infrastructure for big data analytics and examining modern approaches in evidence generation to support regulatory decisions. Special emphasis is placed on systems thinking in regulatory science research to facilitate development and adoption of new solutions for improving efficiency, reliability, and productivity in a broad range of workflows related to drug development and regulatory decision making.

In addition, INFORMED is actively pursuing the development of programs to support creation of a knowledgeable, sustainable, and agile data science workforce capable of addressing the needs of patients in today’s technology-driven and connected world.