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

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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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

You may also be interested in...



FDA Special Protocol Assessments Illuminate Evolution Of Cancer Endpoints

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

Encysive Thelin pivotal trial

Encysive plans to submit an NDA for Thelin (sitaxsentan) for pulmonary arterial hypertension "on or around the end of the first quarter in 2005." The company, formerly Texas Biotech, announced enrollment was complete for the Phase III Sitaxsentan To Relieve ImpaireD Exercise (STRIDE-2) study Sept. 8. The 240-patient, 18-week, double-blind, placebo-controlled trial includes a "third party bosentan [Actelion's Tracleer] arm," Encysive says. Topline data are expected in February 2005. The confirmatory trial is being conducted under FDA's special protocol assessment program (1Pharmaceutical Approvals Monthly Sept. 1, 2003, p. 17)...

Cellegy Cellegesic SPA Clears FDA; NDA Resubmission Planned For Q3 2004

Cellegy’s Special Protocol Assessment agreement with FDA for its anal fissure therapy Cellegesic allows the firm to use pain at three weeks as the primary endpoint for a confirmatory trial.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS002372

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