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

Calling MDUFMA stakeholders: Reauthorization and potential modification of the Medical Device User Fee and Modernization Act of 2002, which expires after fiscal year 2007, will be the focus of the third annual MDUFMA stakeholder meeting in Gaithersburg, Md. Nov. 17. Agenda items include the user fee structure, premarket review performance goals and the third-party inspection program. Attendees must register online by Oct. 28...

You may also be interested in...



NEJM Study Deems CRP Significant, Compared With Other Cardiac Markers

A recent New England Journal of Medicine study identifying C-reactive protein as a significant marker of coronary heart disease risk may prove to be a boon for CRP diagnostic manufacturers

Validating Reuse: Single-Use Device Oversight Taxes FDA Workload

AdvaMed is pressing FDA to review validation data for all reprocessed single-use devices

Chinese Firms Up Their Game In Novel Flu Antiviral Development

Joincare Pharmaceutical and partner TaiGen Biotechnology tout preliminary Phase III results in uncomplicated acute influenza for TG-1000, a homegrown follower of Shionogi/Roche’s oral antiviral Xofluza. Novel antivirals for flu were hotly pursued by Chinese developers throughout 2023.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT022732

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