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U.S. Department of Health and Human Services


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Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop March 31 - April 1, 2009

Silver Spring, MD


The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), the American Thoracic Society (ATS), the Society of Critical Care Medicine (SCCM), and the American College of Chest Physicians (ACCP), regarding scientific issues in clinical trial design for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). This public workshop is intended to provide information for and gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for HAP and VAP, including diagnosis of HAP and VAP, effect of antimicrobial treatment for HAP and VAP, endpoints for trials of HAP and VAP, and statistical issues in analysis of results of trials in HAP and VAP. The input from this public workshop will help in developing topics for further discussion. The FR Notice and the Agenda are listed below. Transcripts to be provided approximately 60 days after the workshop.