Responding to industry pleas for FDA to allow companies to share information about unapproved uses of their approved products, the agency issued a 60-page memo summing up its regulatory history and case law but offering no changes in its approach.
The memo, “Public Health Interests and First Amendment Considerations Related To Manufacturer Communications Regarding Unapproved Uses of Approved Or Cleared Medical Products,” was included in an FDA docket opened for an agency hearing on the issue. FDA explained in a Jan
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