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 Guidance On Health Care Economic Data Is Coming In 2015

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency originally said it would issue a draft guidance on industry’s interactions with formulary committees in 2014, but CDER Director Woodcock says “extremely contentious” issues have slowed progress.

You may also be interested in...

Off-Label Preclearance Process Eyed As Potential Fix For FDA's Policy Dilemma

However, FDA lacks funding to promptly respond to off-label promotion submissions on broad scale; model outlined in settlement of Amarin's Vascepa case could bolster support for third-party vetting system.

Off-Label Questions Linger: How Much Data Needed To Be 'Truthful'?

FDA settlement with Amarin on Vascepa has done little to clarify what constitutes 'non-misleading' communications about an unapproved use.

Off-Label Promotion Settlement Includes Optional Preclearance Process

Amarin may submit up to two proposed communications annually to FDA about unapproved use of its triglyceride-lowering drug Vascepa, and the agency must respond with any concerns within 60 calendar days.

Related Content


Related Companies

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