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

Corticosteroid-Only Arm Worth Public Health Risk In Antifungal Trials - Cmte.

Executive Summary

The benefits of studying a stand-alone corticosteroid arm in a trial comparing an antifungal/corticosteroid combination to an antifungal outweigh public health concerns raised by patient exposure to the corticosteroid, FDA's Dermatologics & Ophthalmics Committee concluded.

You may also be interested in...



Schering Lotrisone Warnings Should Be Milder, FDA Committee Says

Schering-Plough Lotrisone labeling should sufficiently warn against use of the drug in children under 12 but should not be so severe that physicians who use it off label for valid reasons are intimidated, FDA's Dermatologics & Ophthalmics Advisory Committee said.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Latest Headlines
See All
UsernamePublicRestriction

Register

PS036293

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