CDRH Science Council Explains Its Role, Responsibilities
This article was originally published in The Gray Sheet
Executive SummaryCDRH's newly formed Center Science Council has a fairly ambitious to-do list, from developing processes for identifying and integrating new science into FDA reviews to designing new programs to improve clinical trials, according to a draft charter released March 31.
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FDA’s device Center Science Council wants to leverage “big data” and evidence from real-world clinical experience, improve reprocessing of reusable medical devices and enhance use of health information technology and device cybersecurity, among other FY 2016 regulatory science goals.
CDRH Director Jeffrey Shuren says the center is taking multiple steps, including the creation of a new internal subcommittee and possible restructuring to its research offices, in response to critiques from the FDA Science Board on how well CDRH is accomplishing its scientific mission.