HBW Insight 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

US FDA Publishes, Then Withdraws, PDUFA Rates Because Process ‘May Not Be Well Understood’

Executive Summary

User fees for NDAs including OTC switches were set to increase nearly 11% from FY2021 but could have gone even higher; a new notice will be issued but timing is unclear.

You may also be interested in...



Lower FY22 PDUFA Fees Realized In US FDA Recalculation For Hiring, Attrition Concerns

Agency reissued user fee notice, saying fewer dollars were needed for adding staff. After concerns about process misunderstandings, agency withdrew earlier version of fee notice.

US FDA Rebates Biosimilar Fees, Limits Generic Fee Hike In FY 2022

The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.

Pandemic Effect: Sponsors Paid Far Fewer User Fees Than Expected In FY 2020

Revenue increases are expected in FY 2021 over pre-pandemic estimates, in part because the US FDA believes sponsors may have applications that were delayed by COVID-19.

Related Content

Topics

UsernamePublicRestriction

Register

RS151611

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