Pink Sheet is part of the Business Intelligence Division 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
UsernamePublicRestriction

ANDA User Fees Offer Sponsor Relief, But More Facility Pain

Executive Summary

Final GDUFA I application fees decrease amid expected boost in submissions, while facility fees will increase for the fourth time in five years.

Advertisement

Related Content

Another ANDA Submission Surge Begins
ANDA Approvals, Complete Responses Hit Record In FY 2016
GDUFA II: ANDAs, Not Facilities Will Govern Revenue
GDUFA: Review Costs Continued To Climb Once Formal Review Goals Began
ANDA Approvals, Submissions Decline With New Review Goal Coming
GDUFA II: FDA, Industry Reach Tentative 'Alignment' On ANDA Review Issues
Dark, Then Dawn: ANDA Workload Approaching Steady State After 2014 Eruption
GDUFA Fee Adjustments: Facilities Will Pay Less, ANDA Filers More In 2016
FDA's GDUFA War Chest Grows, And Industry May Look For Lower Fees
ANDA Avalanche: How Will FDA Deal With The 600 Received This Month?

Topics

Advertisement
UsernamePublicRestriction

Register

PS118842

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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