FDA has released final guidance to assist sponsors in developing new antibacterial drugs for pulmonary tuberculosis treatment. This guidance finalizes the draft issued in December 2022, aiming to streamline the clinical development process for TB therapies.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Pulmonary Tuberculosis: Developing Drugs for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). This guidance finalizes the draft guidance of the same title issued on December 15, 2022.
Original title: “Pulmonary Tuberculosis: Developing Drugs for Treatment; Guidance for Industry; Availability”