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

Generic Drug User Fees Will Jump More Than 50% In FY 2018

Executive Summary

GDUFA II's fee structure shifts burden from manufacturers to sponsors though 'ANDA holder fee.'

You may also be interested in...



GDUFA III: How Much Of A Fee Increase Can Industry Stomach?

Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.

There's The Bolus! ANDA Sponsors Race To Avoid User Fee Spike

In a year defined by application surges, more than 200 ANDAs were submitted in September, the last month of fiscal year 2017, likely to avoid paying a much higher application fee instituted Oct. 1.

There's The Bolus! ANDA Sponsors Race To Avoid User Fee Spike

In a year defined by application surges, more than 200 ANDAs were submitted in September, the last month of fiscal year 2017, likely to avoid paying a much higher application fee instituted Oct. 1.

Related Content

Topics

UsernamePublicRestriction

Register

PS119329

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