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Off-Label Communication Policy ‘Speech-Enabling,’ FDA Legal Memo States

 
• By Michael McCaughan

The US FDA says in a legal memo that its new guidance on scientific information on unapproved uses (SIUU) is “speech-enabling” and argues that challenges should be interpreted as attempts to roll back the approval process.

Dolls on laptop keyboard in front of screen reading "Freedom of Speech."
(Muhd Imran Ismael/Shutterstock)
Key Takeaways
  • Recently finalized FDA guidance on communicating scientific information on unapproved uses included a memo arguing the policy allows rather than restricts speech.

The US Food and Drug Administration argues that its recently finalized guidance on off-label communication by medical product sponsors does...

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