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US FDA Discourages Off-Label Guidance Suits as Challenges To Entire Approval Authority

 
• 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.

The FDA said BIO/PhRMA marketing principles were not as specific as its policy. (Shutterstock)

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.”

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