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Unapproved Indications Guidance Proves Controversial

Executive Summary

US FDA has collected more than 100 comments on a pair of draft guidance documents about manufacturer speech relating to unapproved devices or information not listed in device labeling. A document allowing manufacturers to disseminate some information not in the labeling drew fire from both sides, with patient groups worrying the change could pose a risk to the public, while trade groups saying the communication protections were still too narrow.

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