Food and Drug Administration
Anti-Infective Drugs Advisory Committee
July 11, 2002
Slides
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