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

PDUFA VI Might Adjust Establishment Fees; FDA Aims For Simplification

This article was originally published in The Tan Sheet

Executive Summary

User fees would need significant restructuring to make up revenue if establishment fees are eliminated, or even just changed, as part of reauthorization. As part of FDA-industry negotiations, several small working groups are expected to be created to deal with specific issues.

You may also be interested in...



The Big Spend-Down: US FDA Eyes $159M Reduction In Carryover User Fees

Agency will substantially reduce amount of human drug and biosimilar user fees that it carries over from year to year by the end of fiscal 2022; carryover generic drug and biosimilar fees will go toward hiring term-limited employees and building capacity, but a technical issue will keep FDA from accessing $79m in PDUFA fees.

The Big Spend-Down: US FDA Eyes $159M Reduction In Carryover User Fees

Agency will substantially reduce amount of human drug and biosimilar user fees that it carries over from year to year by the end of fiscal 2022; carryover generic drug and biosimilar fees will go toward hiring term-limited employees and building capacity, but a technical issue will keep FDA from accessing $79m in PDUFA fees.

PDUFA Negotiations Begin With FDA Seeking Review System Reform

Fee structure changes and process enhancements floated during opening session between industry and agency.

Related Content

Topics

UsernamePublicRestriction

Register

PS108017

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