Food and Drug Administration

Anti-Infective Drugs Advisory Committee

July 11, 2002


Overview of Guidance Development, Dr. John Powers, MD, FDA  htm  ppt

Development of Antibiotics for Otitis Media: Past, Present, and Future, Dr. Janice Soreth, MD, FDA  htm  ppt

Design Issues in Antimicrobial Treatment Trials of AOM, Dr. G. Scott Giebink, MD, U. of Minn. School of Medicine  htm  ppt

Double Tympanocentesis Studies: Bridging From Bacteriological Outcome to Studies With Clinical Outcome, R. Dagan, Beer-Sheva, Israel  htm  ppt

Design of Clinical Trials of Antibiotic Therapy for Acute Otitis Media,  Dr. Colin Marchant, MD, Boston U. School of Medicine  htm  ppt

Study Designs for Acute Otitis Media: What Can Each Design Tell Us?, Dr. C. George Rochester, PhD, FDA  htm ppt

Acute Otitis Media: Lessons Learned, Dr. Thomas Smith, MD, FDA  htm  ppt

Study Considerations: Acute Bacterial Otitis Media, Dr. Rosemary Johann-Liang, MD, FDA  htm  ppt

Acute Bacterial Otitis Media Summary and Charge to the Committee, Dr. Renata Albrecht, MD, FDA  htm  ppt

Open Public Hearing

Application of Pharmacokinetic and Pharmacodynamic Principles to Otitis Media and Other Respiratory Tract Infections, Dr. Michael Jacobs, MD, PhD, U. Hospitals of Cleveland  htm  ppt