ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING

July 10, 2002

Marriott Washingtonian Center, Grand Ballroom, 9751 Washingtonian Blvd., Gaithersburg, MD

NDA 21-242, Artesunate Rectal Capsules, World Health Organization, proposed for the initial management of acute malaria in patients who cannot take medication by mouth and for whom parenteral treatment is not available

8:30 a.m. Call to Order L. Barth Reller, M.D.
Chair, AIDAC

Introduction of Committee

Conflict of Interest Statement Tara P. Turner, Pharm.D.
Executive Secretary, AIDAC

8:40 a.m. Opening Remarks Renata Albrecht, M.D.
Acting Director
Division of Special Pathogen and
Immunologic Drug Products, FDA

8:45 a.m. Sponsor Presentation World Health Organization (WHO)

Dr. Melba Gomes
Special Programme for Research
& Training in Tropical Diseases

World Health Organization
Geneva, Switzerland

Professor Nicholas White
Director, Wellcome Trust
Faculty of Tropical Medicine
Mahidol University
Bangkok, Thailand

Professor Peter Folb
Director, WHO Collaborating
Centre for Drug Policy
Cape Town, South Africa

Professor Fred Binka
School of Public Health
University of Ghana
Legon, Ghana

10:15 a.m. Break

10:30 a.m. FDA Presentation Leonard Sacks, MB.B.Ch.
Medical Reviewer
Division of Special Pathogen and
Immunologic Drug Products, FDA

Ruthanna Davi, M.S.
Statistical Reviewer
Office of Pharmacoepidemiology and
Statisticial Science, FDA

Rosemary Johann-Liang, M.D
Medical Reviewer
Division of Special Pathogen and
Immunologic Drug Products, FDA

Renata Albrecht, M.D.
Acting Director
Division of Special Pathogen and
Immunologic Drug Products, FDA

11:45 a.m. Lunch

1:00 p.m. Open Public Hearing

Swissmedic

1:45 p.m. Charge to the Committee Mark Goldberger, M.D., M.P.H.
Director
Office of Drug Evaluation IV
FDA

2:00 p.m. Committee Discussion

3:30 p.m. Break

3:45 p.m. Continued Discussion and Vote

5:00 p.m. Adjourn