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Inventor Thomas Fogarty’s Newfound Optimism About FDA

In an interview with “The Gray Sheet,” renowned inventor and entrepreneur Thomas Fogarty says he is encouraged, based on his recent experience with FDA, that regulatory trends slowing U.S. device innovation can be reversed.

The idea that risk aversion and opaqueness at FDA are weakening the U.S. medical device innovation model is a truism among large segments of industry. But renowned inventor, entrepreneur and frequent FDA critic Thomas Fogarty says his recent dealings with top CDRH leaders give him reason to hope that the agency is moving in the right direction.

“What you see with FDA now is a change in attitude,” Fogarty said in a recent interview with “The Gray Sheet.” “They do not now want to be a deterrent...

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• By Brian Bossetta

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• By Amanda Maxwell

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• By Amanda Maxwell

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MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

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Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

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

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

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

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.