FDA Flexible On Data Sources, Techniques For Pediatric Device Claims
This article was originally published in The Gray Sheet
Computer modeling, Bayesian hierarchal modeling and use of off-label data sources are among novel methodologies that the device center may accept to demonstrate device effectiveness in kids, officials said Dec. 5.
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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