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
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: