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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. . . .

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