Anti-Infective Drugs Advisory Committee
Food and Drug Administration
Center for Drug Evaluation and Research
Holiday Inn, 8777 Georgia Ave., Silver Spring, MD
"safety and efficacy of 1-day and 3-day dosing regimens of
azithromycin suspension (New Drug Application 50-710, Pfizer Inc.)
for the treatment of otitis media."
Agenda - November 7, 2001
8:00 Call to Order, Introductions - L. Barth Reller, M.D., Chair
Meeting Statement - Thomas H. Perez, M.P.H., Executive Secretary
8:10 Welcome and Introduction - Janice Soreth, M.D., Acting Director,
Division of Anti-Infective Drug Products
8:30 Design of Clinical Trials of Antibiotic Therapy for AOM – Colin Marchant, M.D.,
9:00 Pfizer Inc. Presentation:
Azithromycin in the Treatment of Acute Otitis Media - Michael W. Dunne, M.D., Vice President, Clinical Development, Infectious Diseases, Pfizer Global Research and Development
The Bacterial Pathogenesis of Acute Otitis Media - Edward J. O'Rourke, M.D., Professor of Pediatrics, Harvard Medical School
10:30 Break
10:45 FDA Presentation:
Azithromycin for AOM – Nasim Moledina, M.D., Division of Anti-Infective Drug Products
11:15 Open Public Hearing
12:15 Lunch
1:15 Discussion of Questions and Vote
3:00 Continuation of AOM Clinical Trials Discussion
Introduction – John Alexander, M.D., Division of Anti-Infective Drug Products
Consultants and Guests
Celia Maxwell, M.D., Associate Professor of Medicine, Howard University
Jane L. Burns, M.D., Associate Professor of Pediatrics, University of Washington
Jan Patterson, M.D., Professor of Medicine and Pathology, University of Texas Health Science Center,
Colin Marchant, M.D., Boston Medical Center
Mary Glode, M.D., Professor of Pediatrics, University of Colorado Health Sciences Center
Richard Gorman, M.D., Pediatrics Subcommittee of the AntiInfective Drugs Advisory Committee
Open Public Hearing Participants
Michael R. Jacobs, M.D., Professor of Pathology Case Western Reserve University
Ron Dagan, M.D., Director, Pediatric Infectious Disease Unit, Soroka Medical Center
Sidney Wolfe, M.D., Director, Public Citizen’s Health Research Group