JOURNAL REPRINTS THAT REFERENCE UNAPPROVED USES ALLOWED UNDER FDA PROMOTION REFORM; TEXTBOOK DISSEMINATION PERMITTED IF OFF-LABEL USE NOT "HIGHLIGHTED"
This article was originally published in The Gray Sheet
Executive Summary
FDA will allow companies to disseminate journal reprints of studies used to support an approved indication that include incidental references to off-label uses, the agency says in a Nov. 21 Talk Paper."