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

FDA's Breakthrough Workload Will Be Eased By Hiring Reviewers With PDUFA VI Funds

Executive Summary

User fees won't support dedicated staff, but rather FTEs that will work on the popular program as needed.

You may also be interested in...



Breakthrough Denial Doesn't Mean US FDA Won't Bring Full Resources To Application

Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.

On to PDUFA VII? Yes And No, Woodcock Says, With Sentiment Of Fatigue

The CDER director said the US agency is always thinking about the next iteration of the prescription drug user fee program, but added that it has not yet discussed specifics. 

Competitive Generic Therapy Designations Growing Despite Lack Of Guidance

US FDA developing document describing program operations, but that has not stopped sponsors from requesting and receiving the breakthrough-like designation. 

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS118807

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