The Food and Drug Administration has multi-faceted responsibilities – protect the public health by ensuring safety, efficacy and security of medical & veterinary products, devices, food and cosmetics, regulate the manufacturing, marketing and distribution of tobacco products, speed innovations that make products more effective, safer and more affordable, and ensure the security of the food and medical supply chain by responding to deliberate and naturally emerging public health threats.

These responsibilities require the FDA to continuously monitor trends in science, technology, and data for their impact on public health and to improve the agency’s own efficiency and effectiveness.

To address these objectives, the Technology Modernization Action Plan (TMAP), published in September 2019, laid out a foundation for modernizing the FDA’s technical infrastructure, and signaled the development of the FDA’s ongoing strategy concerning data management and data itself. Specifically, an FDA Data Strategy will focus on the stewardship, security, quality control, analysis, and real-time use of data to accelerate the path to better therapeutic and diagnostic options for people and animals, better secure the food supply chain, and provide state-of-the-art tools to enhance and promote public health.

This follow up document, Data Modernization Action Plan (DMAP), proposes a framework and actionable recommendations for FDA’s Data Strategy. It consists of 3 key components:

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; and,
3. Create and sustain a strong talent network combining internal strengths with key external partnerships.

Click here for Modernization in Action 2022 where we provide many of our accomplishments based on our DMAP and TMAP plans.