Pink Sheet 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

GDUFA: Fee Avoidance Affects Rates Again

Executive Summary

Industry avoided application supplement fees by using CBE submissions instead, forcing FDA to change its estimates and sending generic drug user fees higher.

You may also be interested in...



Generic User Fee Hikes Could Disrupt US FDA Drug Pricing Campaign

New GDUFA program fee is high enough that sponsors may withdraw applications to reduce their fee exposure, agency estimates.

Generic User Fee Hikes Could Disrupt US FDA Drug Pricing Campaign

New GDUFA program fee is high enough that sponsors may withdraw applications to reduce their fee exposure, agency estimates.

Generic User Fee 'Relief' For Small Firms Would Mean Bigger Bills For Large One

Talks between industry and FDA focus on size of the discount and how a small business would be defined.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS055539

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