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News We’re Watching: Expiring Guidance Documents; Multi-Cancer Diagnostic Meeting Set; 510(k)s For BD And Smileyscope

 
• By Hannah Daniel and Elizabeth Orr

This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR treatment for pain and anxiety landed FDA clearances.

Regulatory News We're Watching
• Source: Shutterstock

The first round of pandemic-era guidance documents to be retired after the May ending of the public health emergency are no longer in effect, the US Food and Drug Administration announced on 8 November.

The 16 policies being put to bed largely allowed enforcement discretion for a range of products that were in high demand during the pandemic, such as imaging systems, digital health...

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• By Brian Bossetta

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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
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More from Policy & Regulation

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

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FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

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Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

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