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U.S. Department of Health and Human Services

Drugs

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Design of Clinical Trials of Aerosolized Antimicrobials for the Treatment of Cystic Fibrosis; Public Workshop, September 23-24, 2010

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of aerosolized antimicrobials for the management/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 clinical trial design of aerosolized antimicrobials in patients with cystic fibrosis. The input from this public workshop will help in developing topics for further discussion.

Please note that the meeting will start at 8:00 a.m. on both days of the workshop