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U.S. Department of Health and Human Services


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Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis; Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical trial design for the treatment of tuberculosis. This public workshop is intended to provide information for and to gain perspective from public health care providers, academia, and industry on various scientific aspects of antimicrobial drug development for tuberculosis, including enrollment of patient populations with tuberculosis, effect of antimicrobial treatment for tuberculosis, endpoints for trials of tuberculosis, and statistical issues in analysis of results of trials in tuberculosis. The input from this public workshop will help in developing topics for further discussion.