Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

Exempting User Fees From Sequester Could Take Flight

This article was originally published in The Tan Sheet

Executive Summary

A bipartisan group of House Appropriations Committee members criticize the current policy of FDA user fee revenue being captured by the mandatory budget cuts. FDA Commissioner Margaret Hamburg says losing user fee revenue is “troubling” to the agency and the private sector.

You may also be interested in...



FDA “People Power” Could Take Sequestration Hit – Hamburg

The FDA commissioner says a budget sequester would slow implementation of FDA Safety and Innovation Act provisions and reduce some overseas inspections. More emphasis could be placed on using systems that target the riskiest facilities to reduce the number of onsite inspections, Hamburg says.

Sentinel Could Be Used For Pregnancy Safety Studies Under PDUFA VII

User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.

ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19

First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

Topics

UsernamePublicRestriction

Register

OM011381

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