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US FDA: Development of New Tuberculosis Drug Regimens-Scientific and Clinical Design Considerations

The United States Food and Drug Administration held a public workshop regarding scientific and clinical trial design considerations for development of new tuberculosis drug regimens. This public workshop was intended to provide information for and gain perspective pertaining to development efforts around new in vitro and in vivo models, new biomarkers and tuberculosis diagnostics, assessing the contribution of 2 or more new components used in combination for to a tuberculosis regimen and clinical trial design challenges.

The TB Workshop transcript is available here and the details of the workshop are on the FDA's website

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