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

FDA FY 2004 approps

This article was originally published in The Gray Sheet

Executive Summary

AdvaMed June 18 "fly-in" will bring member CEOs to Congress to advocate additional funds for device user fee program. On that day, AdvaMed plans to unveil the Senate Medical Technology Caucus. Regarding user fees, an April 11 letter from Senate HELP Committee Democrats to Senate Appropriations/Ag Subcommittee Chairman Robert Bennett (R-Utah) seeks a $28.5 mil. increase in the FY 2004 FDA budget to sustain the program and help the agency meet performance goals. Bennett is expected to meet with individual device execs in May...

You may also be interested in...



Thompson on user fees

Additional Medical Device User Fee & Modernization Act funds are forthcoming, HHS Secretary Tommy Thompson assures FDA Science Forum attendees April 24 in Washington, D.C. Responding to an audience query about the role of the Office of Management & Budget in device appropriations, Thompson reported that FDA Commissioner Mark McClellan "advanced the budget with the money in, and we advanced it to OMB. I didn't realize that in America we had a 'Super God' until I came to Washington, D.C., and I found out [it] is OMB. Congress is going to respond.... We have to work within the guidelines with OMB, [but] at the end of the day...I am absolutely certain there's going to be some additional money" for devices. Industry is seeking a $28.5 mil. increase in the FY 2004 FDA budget to sustain the user-fee program (1"The Gray Sheet" April 21, 2003, In Brief)...

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Partisan Politics Returns To US FDA Congressional Oversight

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT018232

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