FDA "seal of approval" labeling may be addressed in guidance -- agency's Sheehan.
This article was originally published in The Tan Sheet
Executive Summary
FDA "SEAL OF APPROVAL" GUIDANCE UNDER CONSIDERATION to clarify for manufacturers the various labeling statements they can make about agency approval for different types of drugs and medical devices. The guidance would expand on a provision of the FDA Modernization Act that repeals a prohibition on making FDA approval claims in product labeling. Use of the approval statements in device labeling likely will be of particular interest to manufacturers of consumer products such as OTC devices and in vitro diagnostics for home use.