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


FDA's Anti-Infective Drugs Advisory Committee

Executive Summary

Will meet Oct. 31 and Nov. 1 at the Parklawn Building, Conference Rooms D & E from 8 a.m.- 6 p.m. each day. The Oct. 31 agenda includes "the use of quinolone class antimicrobials for the treatment of streptococcal infections, including approval standards and review of present knowledge" and an FDA presentation on a draft of the Anti-Infective Drug Division's policy on the need for "two adequate and well-controlled studies" for antimicrobial drug product approvals . On Nov. 1, the committee will hold its discussion on the draft policy and will look at data "regarding the appropriate dosing regimen" for prophylaxis of chloroquine-resistant malaria of Hoffmann-La Roche's antimalarial mefloquine (Lariam, NDA #19-591) and the U.S. Army's mefloquine (NDA #19-578). Copies of the draft policy will be available from FDA's Dockets Management Branch after Oct. 1. . . .

You may also be interested in...

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

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




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