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Compliance Corner: Follow These 11 Steps To Prep For FDA Regulatory Meetings

 
• By Shawn M. Schmitt

Longtime industry expert Steve Niedelman of the law firm King & Spalding offers manufacturers pointers so they’re not caught flatfooted during regulatory meetings with the US agency.

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The US Food and Drug Administration in recent years has taken to holding regulatory meetings with device makers rather than immediately sending warning letters. Preparing for these meetings is critical and will increase the chances of a positive outcome, a longtime industry expert advises.

“Regulatory meetings can be a win-win for both parties, for FDA as well as for industry” – as long as manufacturers follow through on the outcomes of those meetings, said...

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

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

 
• By Amanda Maxwell

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Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• 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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More from Policy & Regulation

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

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