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

Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Transparency proposal feedback: Comments are due July 20 on information FDA is considering making available to the public, the agency noted on its "transparency blog" last week. The agency released 21 draft 1proposals May 19, including ideas such as allowing FDA to publicly explain why it rejects certain product applications, share information about FDA inspections or common inspection problems, and give doctors and patients summaries of safety and effectiveness data from medical product applications (2"The Gray Sheet" May 24, 2010)

You may also be interested in...



CDRH Pre-Market Reform Proposals Expected Within Weeks

The FDA device center's upcoming proposals for reforming its pre-market policies will directly address widespread industry concern that reviews are increasingly unpredictable and opaque, CDRH Director Jeff Shuren told an industry audience last week

FDA Unveils 21 Policy Changes To Increase Transparency With Public

FDA may publicly disclose more information on specific devices prior to marketing approval under a May 19 proposal to increase transparency

Attendees Air 510(k) Concerns At CDRH Town Hall In Minnesota

Not surprisingly, questions and fears surrounding 510(k) reform dominated a "town hall" forum held by CDRH Director Jeffrey Shuren and other center managers in Minneapolis May 18

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT029151

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