FDA Policy/General

Information Technology Operating Plan Posted

The FDA Office of Digital Transformation (ODT) has posted the FDA Information Technology (IT) Operating Plan, described as a “milestone in the agency’s technological evolution.” An online post (contains a link to the plan) says the plan sets forth strategies and initiatives to enhance service delivery to the public.

ODT says the plan emphasizes transparency, collaboration, and accountability, and underscores FDA’s proactive leadership in IT initiatives. “The agency aims to drive innovation and efficiency across its operations by fostering collective efforts and leveraging technology and data,” the post says. “Anticipating the dynamic nature of the environment, FDA commits to regular reviews of the IT strategy and operating plan.”

ODT says it also published its 2023 annual report, highlighting 11 key successes: developing an IT strategy, engaging stakeholders for success, enhancing inspection of foreign products, cloud-based backup and recovery, strengthening cybersecurity, improving collaboration outside FDA, adopting artificial intelligence, introducing data analytics as a service, developing new data scientists, and inspiring future IT professionals.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome