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 Encourages Pediatric Master Protocols With Bayesian Approach

Executive Summary

Most trials currently use of frequentist statistics, but agency argues that Bayesian methods allow for better extrapolation.

You may also be interested in...



Mutual Recognition's Next Evolution May Be Sharing Info On India And China Inspections

Now that US FDA has approved the final EU authority, mutual recognition efforts could expand and deepen. Former FDA chief counsel Rebecca Wood discusses the future of approval standards harmonization in Pink Sheet interview.

US FDA's Brexit: One Staffer Moving, But Impact Still May Loom Large

Uncertainty about Brexit's impact on the FDA-EMA mutual recognition agreement are among issues worrying regulators as countdown continues to the UK's departure from the EU.

Orphan Drug Development: Could We Be Seeing The End Of P Values?

Panel of experts stresses need to move toward innovative approaches for rare disease drug development such as Bayesian methods, but this would require a paradigm shift in US FDA's regulatory structure. 

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119209

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