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

As Biosimilar Meeting Requests Rise, So Do FDA's Performance Goal Challenges

Executive Summary

Growing number of products participating in BsUFA program, coupled with budgetary challenges, have made FDA attainment of some early goals under the Biosimilar User Fee Act difficult.

You may also be interested in...



FDA Proposes Dedicated Biosimilar 'Unit' For BsUFA II

New unit could help better coordinate policy, operations and other biosimilar functions, FDA tells industry.

FDA Met Biosimilar Review Timelines But Missed Meeting Goals In 2015

Agency's biosimilar meeting workload rose slightly; shifts in types of meetings may reflect maturation of individual biosimilar development programs.

Biosimilar Market Formation Isn't Going According To Plan

As user fee negotiations begin, FDA has far more sponsors in product development phase and far fewer marketing applications than anticipated.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1122310

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