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Chevron’s Fall Strengthens Industry’s Hand In Disagreements With US FDA, But May Create Delays

 
• By Sue Sutter

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

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What types of FDA disputes are ripe for litigation in a post-Chevron world? • Source: Shutterstock

[Editor's note: This story appeared first in our sister publication, Pink Sheet.]

Biopharma companies that have a prelitigation dispute with the US Food and Drug Administration will be in a stronger position...

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FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By Elizabeth Orr

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Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
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More from Policy & Regulation

FDA’s Small Business Eligibility Process Gets Update Before New Fiscal Year

 
• By Elizabeth Orr

The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.

Bipartisan Senate Bill Would Give Patients ‘True Price Tag’ Prior To Care

 
• By Brian Bossetta

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How Notified Bodies Would Like Future EU Medtech Governance To Pan Out

 
• By Amanda Maxwell

Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.