FDA Releases Pulmonary Tuberculosis Guidance

FDA has released a draft guidance, Pulmonary Tuberculosis: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs for the treatment of pulmonary tuberculosis. The guidance document addresses the overall development program and clinical trial designs for drugs to support an indication for the treatment of active pulmonary tuberculosis. The guidance applies to the development of a single investigational drug as well as to the development of two or more new investigational drugs for use in combination.