Design of Clinical Trials of Aerosolized Antimicrobials for the Treatment of Cystic Fibrosis; Public Workshop

摘要

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of aerosolized antimicrobials for the management and/or treatment of patients with cystic fibrosis. Aerosolized antimicrobials are used to treat chronic bacterial infection in the lungs and thus improve the respiratory symptoms in patients with cystic fibrosis. This public workshop is intended to provide information for and gain perspective from health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of the design of clinical trials of aerosolized antimicrobials in patients with cystic fibrosis. The input from this public workshop will help in developing topics for further discussion. Dates and Times: The public workshop will be held on September 23, 2010, from 8:30 a.m. to 5:30 p.m. and on September 24, 2010, from 8 a.m. to 4 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel,8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited and available only on a first-come, first-served basis. Contact Persons: Chris Moser or Lori Benner, Center for Drug Evaluation and Research,Food and