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

Cystic Fibrosis Trial Endpoints May Be Revised Following FDA Workshop

This article was originally published in The Pink Sheet Daily

Executive Summary

Quality-of-life metrics deserve consideration in addition to lung function in the development of aerosolized antimicrobials, researchers say.

You may also be interested in...



Cystic Fibrosis Trials: CDER Officials Disagree Over Value Of FEV1 Endpoint

There is an apparent split within FDA's Center for Drug Evaluation and Research on the usefulness of measuring the amount of air a patient can blow in one second as a primary outcome measure in trials of aerosolized antimicrobial drugs for cystic fibrosis.

Cystic Fibrosis Trials: CDER Officials Disagree Over Value Of FEV1 Endpoint

There is an apparent split within FDA's Center for Drug Evaluation and Research on the usefulness of measuring the amount of air a patient can blow in one second as a primary outcome measure in trials of aerosolized antimicrobial drugs for cystic fibrosis.

FDA Cites Clinical Investigator In Six Trials Of Three Cystic Fibrosis Drugs

FDA's oversight of clinical trials is becoming an increasingly significant factor in regulatory delays for some products, and a recent warning letter could have a very broad impact: it cites a clinical investigator for six trials related to three separate NDAs

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS071064

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