MedTech Dive September 16, 2021
Dive Brief:
- FDA has reorganized its IT, data management and cybersecurity groups into a new office that will report directly to the commissioner.
- The creation of the Office of Digital Transformation (ODT) is part of a push at FDA to bring its use of technology and data in line with modern practices and to cut duplicative processes.
- FDA is seeking an extra $75.9 million in the 2022 budget to support the modernization plan, which is intended to move the agency away from “antiquated methods” such as manually looking for safety signals in large volumes of PDFs.
Dive Insight:
The establishment of ODT builds on a series of initiatives launched by FDA in recent years. In 2019, FDA released...
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