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

Biosimilar, Generic and Rx User Fees Rely On Different Adjusters For Needed Appropriations

Executive Summary

The biosimilar and generic drug user fees use different CPI measures, meaning they could increase the appropriations needed to allow user fee collection at different rates.

You may also be interested in...



Biosimilars: Does Low BsUFA Fee Revenue Suggest Sponsor Interest Has Stalled?

Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.

Accelerated Approval Could Expand As Alternative To Progressive Approval

CDER Director Woodcock says agency should issue internal and external guidance to promote consistent use of the pathway.

Burgess Not Changing Conflict Of Interest Thinking Despite Flap Over Oral Contraceptive AC

Sponsor of bill that would adjust conflict of interest rules says requiring public release of financial disclosure documents, as one group suggested, may not require a legislative fix.

Related Content

Topics

UsernamePublicRestriction

Register

LL1129552

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