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

Biosimilar User Fee Negotiations Won't Start Until 2016

Executive Summary

Mid-December kick-off meeting puts emerging user fee program on much later track than others.

Advertisement

Related Content

Biosimilar User Fee Talks Reach Starting Line As Report Shows Growing FDA Workload
PDUFA Budgeting: What Will Get Added, Subtracted – Or Multiplied By Cures?
As Biosimilar Meeting Requests Rise, So Do FDA's Performance Goal Challenges
GDUFA II Negotiations: Contract Manufacturers Gain Seat At Table
Biosimilars Forum: How Do You Create A Brand-Generic Coalition? Don’t Talk About Naming
How To Get A Meeting With FDA: Guidance Describes Formal Meetings For Biosimilars
Biosimilars Program Will Be “Under-Resourced” In Early Years As Industry Grows
Biosimilar User Fee Agreement Reached, But Will Require Appropriations Boost
Biosimilars: FDA Trying Group-Think Negotiating Strategy For User Fee
PDUFA V Agreement Appears Set Between FDA And Industry

Topics

Advertisement
UsernamePublicRestriction

Register

PS057105

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