FDA Lays Out Tech Modernization Action Plan

Regulatory NewsRegulatory News
| 18 September 2019 | By Zachary Brennan 

As part of efforts to prepare for the continued rise in data-rich applications and to help fill the gap separating scientific advances and new therapies, the US Food and Drug Administration (FDA) on Wednesday unveiled its Technology Modernization Action Plan (TMAP).

Near-term modernization in computer hardware and software technologies are the focus of FDA’s TMAP, which offers a broad overview of how the agency needs to adapt. For instance, the TMAP report notes that FDA will need to have a technical infrastructure that can accept, evaluate and analyze novel sources of data (e.g., real-world data) and apply that data to regulatory decision making over the next several years.

“FDA’s action plan has three elements: (1) modernization of FDA’s technical infrastructure; (2) enhanced capabilities at FDA to develop technology products to support its regulatory mission; and (3) communication and collaboration between FDA and stakeholders, including the technology industry and other government agencies, to drive technological progress that is interoperable across the system and delivers value to consumers and patients,” the report says.

Overseen by FDA’s Office of Information Management and Technology (OIMT), in the coming months FDA will engage with stakeholders to develop a strategy and understanding of common priorities for the agency’s approach to data.

“Issues to address in this context will include: How FDA will ensure that regulatory decisions at the Agency continue to be informed by high-quality data; How FDA will promote efficient data use and data stewardship across the Agency; How FDA will continue its ongoing commitment to a highly secure data and IT environment,” the report notes.

FDA also explains how it will start with “small pilot use case projects” to link regulatory expertise with technology know-how by bringing FDA reviewers and technologists together to target problems and opportunities that will advance modernization efforts.

“These solutions highlight what is possible within FDA’s current environment. Examples for consideration include PrecisionFDA, 7- and 15-day safety reporting for Investigational New Drug (IND) applications, and updating the PREDICT model with machine learning,” the report notes.

The agency will also look to build new technologies to enable real-time FDA operational management dashboards, a collaborative project with Office of the National Coordinator for Health Information Technology on the “life of a data element” and technological solutions for FDA’s import operations.



© 2022 Regulatory Affairs Professionals Society.

Tags: data, FDA, OIMT, TMAP

Discover more of what matters to you

No taxonomy