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 Special Protocol Assessments Illuminate Evolution Of Cancer Endpoints

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s special protocol assessment process is being used overwhelmingly for cancer programs, with more than half of pivotal trial SPAs going to oncologics.

You may also be interested in...



Special Protocol Assessment Requests Up 10%-15% Over FY2002

Sponsor requests for special protocol assessments continue to rise with a 10% to 15% increase so far in 2003, according to FDA.

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals

Product

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS003034

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