Food and Drug Administration

Anti-Infective Drugs Advisory Commmittee

October 29, 2003

Slides

Acute Bacterial Sinusitis - Historical Overview and Goals for Today, Dr. Renata Albrecht, MD, FDA (HTM) (PPT)

Design Issues in ABS Trials: Surrogates Endpoints & Non-Inferiority Trials, Dr. Thomas Fleming, PhD, University of Washington (HTM) (PPT)

Clinical Evaluation of ABS: Diagnostic Considerations, Dr. Carl Kraus, MD, FDA (HTM) (PPT)

Observations From Past Approvals for Acute Bacterial Sinusitis, Dr. Janice Pohlman, MD (HTM) (PPT)

Clinical Trial Design in Acute Bacterial Sinusitis - Considerations for Future Guidance, Dr. John Powers, MD, FDA (HTM) (PPT)