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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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More from Policy & Regulation

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