Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC€™s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA Still Needs Convincing On Use Of Non-Inferiority Trials For CAP – Temple

Executive Summary

Industry has provided little data supporting the use of non-inferiority trials as the basis for approval for community-acquired pneumonia, FDA Office of Medical Policy Director Bob Temple said at a recent workshop on clinical trial design for CAP

You may also be interested in...



FDA Updating Antibiotic Guidances, But Is It Too Late For Some Sponsors?

It was supposed to be a year with a wealth of novel antibiotics, but regulatory concerns turned 2008 from a year of banner antibiotic approvals into a sizeable crop of action letters. Now the delays are taking a serious toll, causing some sponsors to drastically restructure in the face of uncertain and evolving regulatory standards

FDA Updating Antibiotic Guidances, But Is It Too Late For Some Sponsors?

It was supposed to be a year with a wealth of novel antibiotics, but regulatory concerns turned 2008 from a year of banner antibiotic approvals into a sizeable crop of action letters. Now the delays are taking a serious toll, causing some sponsors to drastically restructure in the face of uncertain and evolving regulatory standards

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

UsernamePublicRestriction

Register

PS049259

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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