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 User Fee Rates Will Increase 17% For Fiscal Year 2005

This article was originally published in The Pink Sheet Daily

Executive Summary

Applications including clinical data will cost $672,000. Applications without clinical data and supplemental applications with clinical data will cost $336,000.

You may also be interested in...



User Fee Formula Does Not Account For Greater Number Of Industry-Requested Meetings, FDA Says

An agency white paper reports that increasing drug development costs and thinning pipelines are prompting more companies to seek formal advice from FDA in the IND phase, increasing the agency’s workload.

User Fee Formula Does Not Account For Greater Number Of Industry-Requested Meetings, FDA Says

An agency white paper reports that increasing drug development costs and thinning pipelines are prompting more companies to seek formal advice from FDA in the IND phase, increasing the agency’s workload.

FDA Received More User-Fee Paying Applications In FY 2004 Than Expected

With a “greater than anticipated” number of fee-paying applications received by FDA, the agency collected $5 mil. more than projected at the beginning of the year, the FY 2004 PDUFA Financial Report states.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS060190

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