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

Chart: Amplify: A "De-Risk" Approval?

This article was originally published in The Gray Sheet

Executive Summary

If FDA does approve Amplify, it is not clear that the decision will immediately add a significant amount of new sales for Medtronic, but it could help relieve some pressure on the firm's spine biologics franchise, which is under scrutiny on various fronts.

You may also be interested in...



Regulatory News In Brief

Updated FDA review clock guidance: Agency issues June 30 1guidance detailing the different actions FDA may take on pre-market approval applications and clarifying FDA's timeline goals for applications filed from FY 2008-2012 versus those filed from FY 2003-2007. The 2007 FDA Amendments Act removed interim cycle goals, which often stopped the "review clock" and inadvertently prolonged the review process, maintaining FDA decision goals only. FDA will follow the review goals proposed as part of the new user fee legislation (2"The Gray Sheet" April 23, 2007, p. 7). Cycle goals are also abolished for applications filed in FY 2007. Performance goals will no longer vary from year to year, and FDA now has the option of issuing major deficiency letters for 180-day supplements, as well as for PMAs and panel-track supplements, the guidance points out. The document replaces October 2003 guidance based on the review clock in the 2002 user fee legislation (3"The Gray Sheet" Oct. 13, 2003, p. 22)

Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States

Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.

Metsera Launches As New Obesity Contender Flush With $290m

Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture. 

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT029188

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