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


PDUFA First: Fees To Support Device Center Staff

Executive Summary

To enhance combination product reviews, drug fee revenue will pay for related positions in CDRH.

You may also be interested in...

PDUFA VII: Will Gene Therapy's Rise Influence Talks?

The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.

PDUFA Spending Trends: Fee Revenue Jumps As Percentage Of Funding As Staffing Grows

FY 2018 is first year that US FDA's device center got PDUFA funding for staffers; our infographic shows how CDER is getting an increasing proportion of user fee staff even as other sections of the agency have seen growth over the last five years.

User Fee Draft Suggests Congressional Wariness Of Trump Budget

Discussion draft includes US FDA negotiated user fee amounts well short of the total in recent Trump budget outline.

Related Content


Related Companies

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