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FDA Memo Reiterates Off-Label Enforcement Policy

 
• By Brenda Sandburg

Pre-Trump agency memo on manufacturer communications about unapproved uses says new court rulings and studies on off-label uses and adverse reactions support restrictions; whether agency’s new leadership has the same view remains to be seen.

Responding to industry pleas for FDA to allow companies to share information about unapproved uses of their approved products, the agency issued a 60-page memo summing up its regulatory history and case law but offering no changes in its approach.

The memo, “Public Health Interests and First Amendment Considerations Related To Manufacturer Communications Regarding Unapproved Uses of Approved Or Cleared Medical Products,” was included in an FDA docket...

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

 
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More from Policy & Regulation

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

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Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.