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

Can A Safety Study Support A Superiority Claim? Barely, US FDA Advisors Say

This article was originally published in SRA

Executive Summary

Using a clinical trial originally designed for safety to support an efficacy superiority claim poses unique challenges that can make reliance upon a single study for regulatory purposes potentially risky.

You may also be interested in...



US FDA Approval Versus Patient Access: A Real-World Anecdote

During meeting on real-world evidence, FDA’s Bob Temple describes real-world problem of patient access: his struggles to convince his insurer to cover Lilly/BI's diabetes drug Jardiance – which he helped review.  

Keeping Track: Immuno-Oncologics And Abuse-Deterrent Opioids Take Center Stage (Again); Jardiance CV Claim Approved

The latest drug development news and highlights from our FDA Performance Tracker.

Keeping Track: Novartis' Ribociclib, Tesaro's Niraparib Submitted; Catalyst Clears Path For Firdapse Resubmission

In retrospect, the European Society for Medical Oncology meeting was a showcase for pivotal trial data included in a burst of targeted therapy new drug applications, and more drug development news and highlights from our FDA Performance Tracker.

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS118713

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