The US Food and Drug Administration argues that its recently finalized guidance on off-label communication by medical product sponsors does not run afoul of the First Amendment because it is “speech-enabling.”
Off-Label Communication Policy ‘Speech-Enabling,’ FDA Legal Memo States
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.
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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.
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