Eye on FDA

A series focused on important FDA and related regulatory developments critical to the life sciences industry.

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Eye on FDA

March 12, 2025

The Food and Drug Administration (FDA) has updated its website to provide new information on data integrity concerns relating to medical devices.

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Eye on FDA

December 4, 2024

In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical companies and medical device manufacturers can adopt to mitigate risks related to supply chain disruptions, cybersecurity threats and increased FDA enforcement of quality control and compliance.

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Eye on FDA

November 8, 2024

FDA and the Department of Veterans Affairs (VA) announced last week that they plan to develop the first intergovernmental health artificial intelligence (AI) lab. This lab would test health-related AI applications for safety and effectiveness in a virtual lab environment. VA Undersecretary for Health Dr. Shereef Elnahal announced the news during the Veterans Health Administration Innovation Experience conference. The VA serves 9 million veterans—the largest health system in the country. The VA operates 170 medical centers nationwide, meaning that the VA could be well positioned to serve as a base for AI assurance labs across the country.

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