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Guidance Finalized On Submitting Pediatric Info To FDA In Device Submissions

This article was originally published in The Gray Sheet

Executive Summary

The agency issued its final guidance April 30 on reporting “readily available” information on pediatric subpopulations in device submissions. As with the 2013 draft version, it backs off on a pre-draft proposed rule that would have asked firms to provide data on potential, or possible, pediatric uses of devices.

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