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 Encourages Sponsors Of Hypertension Drugs To Promote Their Cardiovascular Benefits

This article was originally published in The Pink Sheet Daily

Executive Summary

Final guidance allowing class-wide outcomes claims includes suggested language for both advertising and labeling.

You may also be interested in...

Lamictal XR Monotherapy: Will Ex-U.S. Data Invalidate Historical Comparison?

FDA reviewers cite issues with the study design GSK used in its sNDA, but still find evidence of efficacy for partial seizures.

Restanza Superiority Trials Intended To Avoid Non-Inferiority "Quagmire"

Advanced Life Sciences CEO Michael Flavin decided a pair of superiority trials was the best way to prove the efficacy of the company’s Restanza in community-acquired bacterial pneumonia, given the "stalemate" at FDA regarding the use of non-inferiority trials in antibiotics.

Hypertension DTC Ads Should Attribute Benefits To All Blood Pressure Drugs

Antihypertensive drug direct-to-consumer advertisements should include a statement that all drugs that lower blood pressure reduce risk of serious cardiovascular outcomes, members of FDA's Cardiovascular & Renal Drugs Advisory Committee said April 27


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