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'Intended Use' Rule: US FDA May Toss Its 'Totality Of Evidence' Standard

 
• By Brenda Sandburg

Pharma and device industries had complained that rule is overbroad, violates the First Amendment and would increase company exposure to liability.

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The pharmaceutical and medical device industries appear to be making headway in convincing the US FDA to narrow a final rule regarding the evidence the agency considers in determining how a manufacturer intends its product to be used, including whether it is intended for off-label use.

The agency announced that it is proposing to delay indefinitely the rule's implementation. FDA has already delayed implementing the rule...

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