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

Antibiotics For ABS Should Have “Time To Symptom Relief” Trials, FDA Says

Executive Summary

During clinical trials of antibiotics for treating acute bacterial sinusitis, "time to clinical success" is the recommended primary efficacy endpoint, FDA says in new draft guidance on developing ABS drugs

You may also be interested in...



Antibiotic Trial Standards To Be Revised By FDA Under Congressional Mandate

Manufacturers of antibiotics need to get involved as FDA writes clinical trial guidance for antibiotic drugs, according to Bruce Burlington, an independent consultant and former Wyeth VP

Two Strikes For Ketek: Cmtes. Want Bronchitis, Sinusitis Indications Rescinded

FDA's Anti-Infective Drug and Drug Safety and Risk Management Advisory Committees are recommending stripping Sanofi-Aventis' Ketek of its bronchitis and sinusitis indications

Patient-Reported Outcomes Guidance Needs Flexibility, Industry Tells FDA

FDA's draft guidance on patient-reported outcomes (PROs) should offer both greater flexibility and detail, industry commenters told the agency

Latest Headlines
See All
UsernamePublicRestriction

Register

PS048954

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