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


FDA Raising Approval Bar For NSAID/PPI Combos; Endpoints Under Review

This article was originally published in RPM Report

Executive Summary

Regulatory briefings don't always just affect a single product; they can also be convened to discuss the regulatory parameters for a entire product class. One such briefing will be held in early 2009 to discuss the clinical trial design of NSAID/PPI combination products. Pozen is just one sponsor that will be affected by the outcome.

You may also be interested in...

Regulatory Briefings: FDA's "Internal Advisory Committees"

When FDA reviewers need help on a tricky regulatory question, they get advice from top-level officials at an internal meeting called a regulatory briefing. Many sponsors don't even know they exist. But at a time of change in review procedures and staff, companies need to learn how FDA's "internal advisory committees" work.

US FDA Regulatory Affairs Reorg To Include Inspectors Trained In Real-World Evidence, Califf Says

The US FDA Commissioner acknowledged that the inspectorate has not been prepared for RWE, but as part of the revamp, a dedicated team will encourage its use “when it’s appropriate.”


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