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


NDA User Fees Will Climb Almost 16% On Oct. 1

Executive Summary

US FDA completes updates for biosimilars and novel drug fee schedules as PDUFA VI is set to begin.

You may also be interested in...

PDUFA Application Fee Nears $3m Threshold In FY 2020

The US FDA fee for a new drug or biologics license application requiring clinical data will jump to $2.94m in October.

Biosimilars: Rise In US FDA Approvals Means Lower Or Flat User Fees In FY 2020

Fees for applications and approved products will stay the same, while product development levies will fall 36%, the FDA announces. The agency’s biosimilar activities are becoming more reliant on funding from the growing number of products approved and less on those still in development.

US Orphan Fee Waiver Requests Must Include Much More Extensive Documentation

In update of 2011 draft guidance, FDA gives more detail on documentation needed for orphan sponsors to receive a program fee waiver; Guidance also suggests the agency is no longer working with SBA to make small business determinations.

Related Content


Latest Headlines
See All



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