Unmet Medical Needs, Regulatory Barriers Addressed In Public Comments
This article was originally published in The Gray Sheet
Device makers list drug-therapy monitoring tests, venous disease and diabetes treatments, and products targeting children and rare diseases among the top unmet public health priorities for FDA and other government agencies
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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
FDA is considering some "out-of-the-box" ways to get needed device technologies in doctors' hands faster while still ensuring patient safety
Routine sharing of data between FDA and CMS will be possible for the first time under a June 23 memorandum of understanding that could serve as a first step toward parallel reviews for marketing approval and Medicare coverage