Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

CDRH Science Council Explains Its Role, Responsibilities

This article was originally published in The Gray Sheet

Executive Summary

CDRH'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.

You may also be interested in...



‘Big Data’, Device Reprocessing Among FDA's Device Science Goals

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.

Device Center Moves To Better Prioritize Its Scientific Work

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.

When Reviewers Change, CDRH Science Council Seeks Smoother Transitions

The CDRH center science council is developing policies to help ensure smoother transitions when a review team changes during pre-market device reviews.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT029992

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel