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Zdrowie i gospodarka · 6.11.2013

Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Pulmonary Tuberculosis: Developing Drugs for Treatment." The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the development of a single investigational drug as well as development of two or more unmarketed investigational drugs for use in combination.

Source: Federal Register — Food and Drug AdministrationOpen original release →