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Shuren At FDLI: Least-Burdensome, Real-World Evidence Efforts Picking Up

 
• By Elizabeth Orr

US FDA's device-center head discussed his continued push to make regulations more flexible, plans for least-burdensome training and what's next for NEST, among other topics, at the Food & Drug Law Institute annual gathering in Washington DC.

US FDA’s relatively slow path to market may cost small manufacturers more than $40m more than they’d spend in countries with easier device approvals, device-center head Jeffrey Shuren acknowledged at the Food & Drug Law Institute’s Annual Conference May 4 in Washington, DC.

The figure, which was compiled by Versant Ventures, includes $1.8m for eight extra weeks waiting to meet with FDA; $5.5m for a six-month animal study; $10

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Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
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Does Makary’s Reorg Choice Mark FDA Turning Point?

 
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MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
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Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
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More from Policy & Regulation

Does Makary’s Reorg Choice Mark FDA Turning Point?

 
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US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
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NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.