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 Indicates Flexibility On Evidence To Support Efficacy In Pneumonia

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency will seek advisory panel input Nov. 3-4 on options for facilitating trials in community-, hospital- and ventilator-acquired pneumonia.

You may also be interested in...



GAIN Begins (Part 1): FDA Completes Turnaround On Antibiotic R&D

In less than two years, FDA has moved from requiring unrealistic approval standards for antibiotics to exploring innovative ways to shorten the pathway for the most-needed drugs. And, surprise: Congress is on board too. After 15 years, there is finally real momentum on antibiotic drug policy. But is it all enough to get companies back in the game?

Prior Antibiotic Use A Necessary Confounder In Pneumonia Trials, Panel Says

FDA panel chose practicality over preference in suggesting that trials for hospital- and ventilator-acquired bacterial pneumonia can enroll patients who have previously received antibiotics.

One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says

Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.

Related Content

Topics

UsernamePublicRestriction

Register

SC143162

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