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

FDA’s Benefit/Risk Framework Turns 10: A Quietly Critical Innovation

Executive Summary

In finalizing a guidance on its approach to the fundamental benefit-risk assessment for new drug reviews, US FDA affirms the central role of the qualitative benefit-risk framework tool that was rolled out a decade ago.

You may also be interested in...



US FDA's Benefit/Risk Framework Gets High Marks But Could Be Improved

Agency summaries contained in reviews of novel drugs and biologics are useful and informative but difficult to find, and their use should be expanded to other types of applications, industry sponsors and other external stakeholders say.

FDA’s Structured Benefit-Risk Assessment Framework To Come Online In FY 2014

Drug reviews will include a benefit-risk summary assessment that states the rationale for regulatory action on a drug or biologic application and explains how differences of opinion among reviewers were resolved.

Pragmatic Oncology Trials: Survival Is Only Viable Endpoint For Now; FDA Emphasizes Streamlining

Overall survival is the only viable endpoint for pragmatic trials in oncology, the US FDA and a panel of stakeholders agree, although other novel endpoints could be validated over time. In the meantime, FDA says, sponsors should focus on other aspects of trials that can be streamlined.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS149069

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