Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


Kennedy Opposition Halts Device User Fee, Third-Party Expansion Momentum

This article was originally published in The Gray Sheet

Executive Summary

House and Senate conferees are likely to include Prescription Drug User Fee Act (PDUFA) reauthorization and medical device reforms in the Public Health Security and Bioterrorism Response Act of 2001 (HR 3448) when they meet to reconcile the measure, as early as the week of April 15

You may also be interested in...

Tauzin Will Tackle Device Reforms Outside PDUFA; Eshoo Urges Hearings

House Energy & Commerce Committee Chairman Billy Tauzin (R-La.) will work with medical device reform bill sponsors to move HR 3580 independently of Prescription Drug User Fee Act reauthorization

Device User Fee Proposal To Be Discussed By HIMA Board At Annual Meeting

A discussion on device user fees between a top health official in the Office of Management and Budget and the Health Industry Manufacturers Association board of directors suggests stepped-up efforts by the White House to generate support for its budget proposal and a potential willingness on the part of large device firms to reconsider their past opposition to user fees.

Basilea Stresses Derazantinib's FGFR Kinase Differentiation

Switzerland’s SIX exchange-listed drug development company, Basilea, is moving two new oncology candidates along its R&D pipeline, supported by strong revenues from two partnered anti-infective products.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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