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

Biosimilars: FDA Trying Group-Think Negotiating Strategy For User Fee

Executive Summary

FDA seems content to negotiate a user fee for biosimilars in a manner that typifies the composition of the products: similar, but not the same, as the other user fee programs.

You may also be interested in...



Biosimilar User Fee Negotiations Won't Start Until 2016

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

User Fee Conference Committee Targets Settling Differences In June

A conference committee tackles differences between House and Senate FDA user fee and agency reform bills, with an agreement expected before the end of June.

User Fee Conference Committee Targets Settling Differences In June

A conference committee tackles differences between House and Senate FDA user fee and agency reform bills, with an agreement expected before the end of June.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS053390

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