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‘Never Again’: Shuren Talks COVID-19 Lessons At FDA Small Business Event

 
• By Elizabeth Orr

Despite insisting that he would never want to relive the stressful days of 2020, US FDA device center chief Jeff Shuren said the pandemic nevertheless led to improvements in regulatory flexibility and communication with industry.

Device center headquarters on the US FDA's Maryland campus.
• Source: Alamy

US Food and Drug Administration device center director Jeff Shuren had a simple answer when asked on Monday how he’d summarize 2020: “Never again.”

Nevertheless, the painful year led to significant – and possibly lasting – changes at the Center for Devices and Radiological...

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• By Ashley Yeo

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Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.

Warning Letters - July 2025

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