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

ANDA Submissions To US FDA Expected To Decline; Generic User Fees For FY 2019 Will Rise

Executive Summary

FDA's predictions have been pretty consistent; actual submissions haven't been.

You may also be interested in...



GDUFA Sees First-Ever Fee Spending Decrease

Thanks in part to budget authority bump, US FDA’s generic user fee revenue spending dropped in FY 2019, and hiring problems lead to an FTE decrease. The useable GDUFA carryover balance also increased in conjunction with the user fee revenue spending reduction, from $158.7m available at the end of FY 2018 to $199.2m at the end of FY 2019.

Generic Drug User Fee Program Sees First-Ever Fee Spending Decrease, FTE Decline

Thanks in part to budget authority bump, US FDA’s generic user fee revenue spending dropped in FY 2019, and hiring problems lead to an FTE decrease. The useable GDUFA carryover balance also increased in conjunction with the user fee revenue spending reduction, from $158.7m available at the end of FY 2018 to $199.2m at the end of FY 2019.

FDA Reports Millions In Unpaid GDUFA Fees

The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.

Related Content

Topics

UsernamePublicRestriction

Register

PS123582

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