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US FDA Extends Payor Communications Safe Harbor To Off-Label Uses

 
• By Brenda Sandburg

Final guidance on drug manufacturer communications with payors adopts industry call to include exchanges about unapproved uses; they will not be considered evidence of intended use.

Guidance word in red keyboard buttons

The US FDA is allowing firms to share certain information about the unapproved uses of approved products in their communications with payors.

The agency specified that the exchange is permissible in

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