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Payer Communications Safe Harbor Should Extend To Off-Label Uses – Industry

 
• By Sue Sutter

US FDA should apply same regulatory protections to manufacturer communications with payers about unapproved uses that agency draft guidance provides to information exchanges about investigational products, biopharma companies say.

Drug manufacturer communications to payers about off-label uses of approved products should be protected from US FDA enforcement if those uses are being actively studied or undergoing regulatory review, biopharma companies say.

In comments on FDA’s draft guidance on payer communications, industry groups and individual companies urge FDA to provide information exchanges about data on new indications the same safe harbor

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