Federal Register #FDA2013D1319

FDA Final Guidance on Developing Drugs for Pulmonary Tuberculosis

The Food and Drug Administration (FDA) has released a final guidance document for industry on developing drugs to treat pulmonary tuberculosis (TB): - Government buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - Provides updated regulatory guidance for sponsors developing new antibacterial drugs for pulmonary TB - Covers nonclinical and safety considerations, study populations, efficacy endpoints, and trial design - No procurement activity: - No products, services, OEMs, or vendors are requested or mentioned - No quantities, part numbers, or contract values provided - Notable details: - Guidance is available for download and review on federal websites - Document represents FDA's current thinking and is not binding - Locations referenced: - FDA headquarters in Silver Spring, MD - Federal Register as publication source

Description

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry titled "Pulmonary Tuberculosis: Developing Drugs for Treatment." This guidance assists sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). It finalizes the draft guidance issued on December 15, 2022, and includes updates on nonclinical and safety considerations, study populations, efficacy endpoints, and trial design considerations. The guidance represents the current thinking of FDA and is not binding.

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