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

Senate Plans FDA User Fee Markup This Week; House Not Far Behind

This article was originally published in The Gray Sheet

Executive Summary

Updated draft user fee reauthorization bills issued last week reflect works in progress as lawmakers aim to reach consensus on FDA reforms.

You may also be interested in...



Fireworks Kept At Bay As Congress Pushes To Enact FDA Reforms By July 4

Bipartisan FDA user fee reauthorization and reform legislation sailed unanimously through the House Energy and Commerce Committee May 10, with many similarities to a Senate version that has also passed out of committee.

Senate Committee Moves Bipartisan FDA Reform Bill Toward Floor

Legislation was reported out of committee last week, with some additional amendments under consideration as the user fee reauthorization bill moves closer to the Senate floor. House members still struggle to reach consensus.

CDRH Plans To Redraft Maligned 510(k) Modifications Proposal

Center Director Jeffrey Shuren says it was not CDRH’s intention to force more 510(k)s for device modifications with its July 2011 draft guidance. The center plans to take the unusual step of issuing a revised draft to respond to industry complaints.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT031156

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