FDA Introduces Technology Modernization Action Plan (TMAP)How often do you hear about a new and exciting scientific or biomedical advancement...
How often do you hear about a new and exciting scientific or biomedical advancement and then wonder when it will become available to the millions of Americans who might benefit from it? I’m sure it’s often, and the U.S. Food & Drug Administration (FDA) will tell you that it’s only going to happen more frequently in coming years.
To prepare for the increase in and complexity of these advancements, and to ensure that the FDA continues to carry out its regulatory mission, the agency is implementing a near-term Technology Modernization Action Plan (TMAP) that will enable it to lessen the gap between scientific advancement and available technologies. The three-year initiative should translate into more therapies for patients and an overall improvement in public health.
The plan includes three important elements: (1) modernizing the FDA’s technical infrastructure, (2) supporting its regulatory mission by developing better technology products, and (3) collaborating with stakeholders to foster technological progress that can be realized across the system as a value to consumers and patients. Below is a look at how these three elements will be carried out.
Modernization of infrastructure
At the center of the FDA’s technology modernization plan are computer hardware and software technologies. The agency has identified these two areas as necessary for an important goal — to receive, store, analyze, and exchange the complex data that accompanies scientific advancement. The Office of Information Management and Technology (OIMT) will be responsible for modernizing the way data is managed; once that effort is successful, the FDA’s many programs will be able to use that data in regulatory decision-making.
The modernization should also allow the FDA to accommodate the increase in its review workload. Together, these provisions should promote innovation not only within the FDA but also in the expanded healthcare community.
The FDA will develop necessary technological capabilities to efficiently evaluate and foster new advancements that inform regulatory decision-making. The agency wants to develop technologies that demonstrate current FDA possibilities and products that can be adapted to different program areas within the FDA, thus reducing duplication of products.
Additionally, the FDA would like to develop “minimum viable products for testing” and transition to a flexible “devops” mindset in a collaborative culture where improved user experience, satisfaction, and adoption are the goals. Success should show what a modern FDA is able to accomplish in the next few decades.
Collaboration for success
The FDA wants the modernization to be influenced by the engagement of its stakeholders, with broad input. The agency is committed to facilitating a variety of platforms where this can take place, including public meetings, workshops, and even online environments where technology products can be tested by external participants. The result should be a collection of high-quality data that ensures the quality of the FDA’s regulatory mission.
The FDA wants to provide transparent implementation of TMAP, so regular public updates will be announced.
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