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


Pharmacometric Reviews Increasingly Influence FDA Regulatory Decisions

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Drug makers should routinely perform exposure-response analyses across Phase II and III studies to find consistencies across trials, FDA said in a recent survey of 31 NDAs submitted between 2005 and 2006.

You may also be interested in...

What Not To Do: FDA Reviewer Talks Cancer Drug Development Mistakes

Using anonymous examples at the recent AACR meeting, FDA’s Tatiana Prowell highlights mistakes made and lessons learned in oncology drug reviews.

Industry Urges FDA To Move Faster In Using Models For Regulatory Decisions

FDA holds the key to making model-based drug development and drug-disease model libraries successful, speakers at a Jan. 24-25 Drug Industry Association meeting concluded

Pfizer Chantix Review Shows Pitfalls Of Patient-Reported Outcomes

The debate over analysis of clinical trial endpoints in FDA review documents for Pfizer’s Chantix (varenicline) provides a window into how the agency’s view of smoking cessation trial design is changing as new therapeutic classes emerge.

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