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Off-Label Communications: US FDA Clarifies Safe Harbor For Firm-Generated Presentations

 
• By Sue Sutter

Final guidance on communicating scientific information on unapproved uses (SIUU) allows firm-generated presentations to be based on sources other than reprints, but says communications based on nonscientific content are not protected from enforcement.

Harbor with boats
The FDA's final guidance on SIUU establishes a safe harbor for some manufacturer communications to healthcare providers about off-label uses. (Shutterstock)

The US Food and Drug Administration’s final guidance on communications to healthcare providers about off-label uses takes a hard line against using nonscientific content in firm-generated presentations.

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