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.
You may also be interested in...
Industry Largely Supports FDA’s New Proposal On Pediatric Data Submission
Device companies are generally happy with FDA’s rewrite of a rule requiring information on pediatric populations suffering from conditions their devices are intended to treat. The American Academy of Pediatrics is less pleased.
FDA Withdraws Pediatric Data-Submission Rule, But Aims To Regroup Shortly
FDA has 1withdrawn a new regulation that would have required companies to submit additional pediatric patient data as part of pre-market submissions beginning next month, but says it hopes to finalize a possibly revised version soon
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.