Guidance Finalized On Submitting Pediatric Info To FDA In Device Submissions
This article was originally published in The Gray Sheet
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...
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 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
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.