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
UsernamePublicRestriction

Generic User Fee Talks: Performance Metrics For Early Years Still Unresolved

Executive Summary

Industry and FDA appear largely in agreement on goals for the generic drug user fee program after it gets off the ground, but are stuck on how to determine agency performance in its early years.

You may also be interested in...



ANDA User Fee Negotiations Finished; Backlog To Be Mostly Cleared By Year Five

The finalized generic drug user fee agreement would clear most of the ANDA application backlog by the end of the first program cycle.

ANDA User Fee Negotiations Finished; Backlog To Be Mostly Cleared By Year Five

The finalized generic drug user fee agreement would clear most of the ANDA application backlog by the end of the first program cycle.

Generic Drug User Fees Will Begin With The Backlog

FDA set aside fears that a separate fee for the application backlog would create administrative problems for its generic drug user fee program, instead choosing to use the queue of pending submissions to help gain more funding at launch.

Related Content

Topics

UsernamePublicRestriction

Register

PS053574

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