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

Antibiotic Non-Inferiority Trials To Be Addressed By FDA Advisory Committee

Executive Summary

Antibiotic drug sponsors may get more clarity on FDA's policy for non-inferiority margins following the conclusion of a three-day Anti-Infective Drugs Advisory Committee meeting in November

You may also be interested in...



Patient Dropouts, Other “Missing Data” To Be Addressed In FDA Guidance

FDA hopes two guidances - one on non-inferiority margins and another on how to handle missing data in clinical trials - will better direct industry in developing clinical trials and extrapolating more accurate data

Patient Dropouts, Other “Missing Data” To Be Addressed In FDA Guidance

FDA hopes two guidances - one on non-inferiority margins and another on how to handle missing data in clinical trials - will better direct industry in developing clinical trials and extrapolating more accurate data

Guidance on Anti-Infective Non-Inferiority Margins May Not Be Clear-Cut

FDA is expected to provide some much-desired clarity on its policy for non-inferiority margins in clinical trials for anti-infectives at this week's advisory committee meeting. But the end result may not be the concrete answer that industry is hoping for

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS050223

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