Industry: Off-Label Rules Mustn’t Rule Out Public Forum Discussions

The FDA should revise draft off-label guidance to ensure devicemakers can respond immediately to unsolicited questions on off-label uses posed in public forums, industry maintains. In comments on the December draft, AdvaMed said it “raises confusion through impractical or at times limited examples.” The group also complained that some of the draft’s language is too restrictive.
Devices & Diagnostics Letter