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

US FDA User-fee Bill Will Pressure Budget In 2023

Executive Summary

A provision in the FDARA user-fee bill prevents FDA from spending user-fee revenue on building maintenance costs beginning in FY 2023, which could deter future recruitment and retention of the "world's best and brightest" scientists at FDA, House Energy and Commerce ranking member Frank Pallone says.

You may also be interested in...



US FDA User-Fee Bill Swiftly Passes US House, Now Moves To Senate

The FDA Reauthorization Act, which would reauthorize the MDUFA IV user-fee agreement and enact additional device regulatory reforms, passed the US House July 12 on a unanimous vote. Lawmakers applauded the bill's inclusion of device facility inspection reforms and an over-the-counter hearing aid provisions. The legislation now moves to the Senate, where a crowded legislative schedule could mean delayed consideration.

House Budgeters Give FDA Device Center Slight Bump In 2018

A US FDA funding bill approved by a House subcommittee would allot the agency's device activities a total of $487.8m for FY 2018, including user fees and budget appropriations. Overall, CDRH would see a slight, $67.2m bump in funding.

US FDA's Gottlieb Wants Safety Built Into New Medtech Products, But Budget Will Be Cut To Surveil Older Ones

President Trump's proposed budget cuts to the agency's post-market surveillance programs means that more "faulty" devices, such as St. Jude defibrillators and Bayer HealthCare's Essure birth control coils, will cause harm rather than be recalled, Rep. Rosa DeLauro said at a May 25 House Ag/FDA subpanel hearing. FDA Commissioner Scott Gottlieb told DeLauro the agency needs to supply "the right tools" to firms during device development so similarly flawed devices aren't put on the market, and he noted that the lifting of a hiring freeze at the agency earlier in the day would free the agency to work harder on such issues.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT105150

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