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

Advisory Committee Splits The Difference On CABP Trials

Executive Summary

A fierce dispute between researchers and clinicians who think community-acquired bacterial pneumonia drugs should be evaluated by their effect on mortality, and those who favor symptom-based evaluation, is unlikely to be quelled by actions taken at the Dec. 9 meeting of FDA's Anti-Infective Drugs Advisory Committee, which gave each side some of what it wanted

You may also be interested in...



Pneumonia Guidances Revisited: FDA Cmte. To Weigh Study Design Issues Again

FDA’s Anti-Infective Drugs Advisory Committee will take its third look in less than four years at standards for developing antibacterial agents to treat community-acquired bacterial pneumonia, at a meeting on Nov. 3.

Pneumonia Guidances Revisited: FDA Cmte. To Weigh Study Design Issues Again

FDA’s Anti-Infective Drugs Advisory Committee will take its third look in less than four years at standards for developing antibacterial agents to treat community-acquired bacterial pneumonia, at a meeting on Nov. 3.

Meningococcal Serogroup B Vaccines Can Be Approved With Surrogate Endpoints, FDA Says

Traditional placebo-controlled trials would require an impractically large patient population, the agency says as it seeks advisory committee input on post-marketing requirements.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS051772

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