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
UsernamePublicRestriction

Tiered And Backlog Generic User Fees Are Possible But Create Challenges For FDA

Executive Summary

Ideas for tiered and backlog user fees for generic drug applications remain possibilities, but appear to face significant hurdles to becoming part of any program because of administrative and other issues that would come with them.

You may also be interested in...



GDUFA Talks: FDA Reminds Industry The Program Is Generic-Only

Generic drug user fee negotiations began with a reminder that components of the program will not apply to other regulated drug sectors.

GDUFA Talks: FDA Reminds Industry The Program Is Generic-Only

Generic drug user fee negotiations began with a reminder that components of the program will not apply to other regulated drug sectors.

Generic User Fees: FDA Reaches Out To More Trade Groups; Plan Could Mix Inspection and Application Fees

FDA continues to mull inspection- and application-based proposals for a generic drug user fee, but before beginning negotiations it wants comments from a wider breadth of the industry.

Topics

UsernamePublicRestriction

Register

PS052997

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