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

FDA's GDUFA War Chest Grows, And Industry May Look For Lower Fees

Executive Summary

Two years into collecting generic user fees, FDA has more than $277 million in unspent dollars.

You may also be interested in...



GDUFA III Calculation Faces Rising Staff Costs

After dialing back the inflation adjustment in GDUFA II, FDA’s ANDA review program now faces rising personnel costs, in contrast to the agency overall, suggesting that GDUFA III might need a more tailored formula.

Generic Drug User Fee Projections Complicated By Shifting Personnel Costs

After dialing back the inflation adjustment in GDUFA II, FDA’s ANDA review program now faces rising personnel costs, in contrast to the agency overall, suggesting that GDUFA III might need a more tailored formula.

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS056919

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