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Off-Label Use Final Rule: US FDA Declines To Focus Solely On Promotional Claims

 
• By Brenda Sandburg

In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.

Off label
FDA issues final rule for determining off-label use of medical products • Source: Alamy

The US Food and Drug Administration declined to limit the types of evidence it will consider in determining if a product is being marketed for its intended use, rejecting industry requests that it focus solely on promotional claims.

FDA issued its final rule on intended use in a Federal Register notice to be published on 2 August....

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