Food and Drug Administration

Anti-Infective Drugs Advisory Committee

October 14, 2004


When Blood & Guidance Go Bad: The Story of Bacteremia as an Indication, Dr. Janice Soreth, MD (HTM) (PPT)

Bacteremia and CRBSI as Labeled BSI Indications: A Regulatory History, Dr. Alfred Sorbello, FDA (HTM) (PPT)

Staphylococcus Aureus Bacteremia, Dr. Sumathi Nambiar, MD, MPH, FDA (HTM) (PPT)

Microbiological Considerations in Diagnosing S. Aureus Bacteremia, Dr. Patrick Murray, PhD, NIH (HTM) (PPT)

Clinical Trails Considerations in Primary Bacteremia Due to Staphylococcus Aureus, Dr. John Powers, MD, FDA (HTM) (PPT)

Catheter-Related Bloodstream Infection Guidance Revisited, Dr. Janice Pohlman, MD, FDA (HTM) (PPT)

Issues for Discussion: Clinical Trials Considerations in Primary Bacteremia Due to Staphylococcus Aureus (HTM) (PPT)

Open Public Hearing

Presentation by Dr. Francis Tally, MD, Cubist Pharmaceuticals, Inc., Staphylococcus Aureus Bacteremia and Endocarditis (HTM) (PPT)

Presentation by Dr. Tim Henkel, MD, PhD, Vicuron Pharmaceuticals, Catheter-Related Blood Stream Infections - A Phase 2 Randomized, Controlled Trial of Dalbavancin vs. Vancomycin (HTM) (PPT)

Presentation by Charles Knirsch, MD, MPH, Issues in Conduct of Catheter Related Infection (CRI) Studies (HTM) (PPT)