FDA lays out tech modernization action plan
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 FDA on Wednesday unveiled its Technology Modernization Action Plan (TMAP).
Near-term modernization in computer hardware and software technologies are the focus of the FDA’s TMAP, which offers a broad overview of how the agency needs to adapt. For instance, the TMAP report notes that the 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.
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