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FDA Announces More Actions On Drug-Coated Devices

 
• By Elizabeth Orr

The US FDA’s latest update on the safety of paclitaxel-coated balloons and stents urges additional clinical trials. The agency also plans updates to device labeling and clinical trial informed consent documents that will reflect evidence that the devices may pose a mortality risk.

FDA entrance sign 2016

More long-term clinical trials are needed to investigate a possible mortality risk tied to paclitaxel-coated balloons and stents, the US Food and Drug Administration said in a 7 August update concerning the devices.

Paclitaxel coatings have been the subject of ongoing FDA scrutiny since a meta-analysis of randomized trials published in the Journal of the American Heart Association in December 2018 found...

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• By Elizabeth Orr

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Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

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Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

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