Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Generic Drug User Fees Will Begin With The Backlog

Executive Summary

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.

You may also be interested in...



Inspection Improvements Could Help Fight Drug Shortages, Hospital Group Says

Senators also have requested a GAO study of the nature of drug shortages and FDA's ability to respond to them.

FDA Reshuffles Office Of Generic Drugs To Improve Performance

The generic drug industry can expect more streamlined reviews as a result of FDA's reorganization of the Office of Generic Drugs, according to the agency.

FDA Reshuffles Office Of Generic Drugs To Improve Performance

The generic drug industry can expect more streamlined reviews as a result of FDA's reorganization of the Office of Generic Drugs, according to the agency.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS053691

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