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The document gives guidance on the limited population pathway for antibacterial and antifungal drugs.
FDA announced on August 5, 2020 the publication of Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry. In the document, FDA describes considerations for “demonstrating the safety and effectiveness of limited population antibacterial and antifungal drugs.” The guidance was developed as part of a requirement in section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 3042 of the 21st Century Cures Act, to assist in the development of new antibacterial and antifungal drugs.
The guidance offers information on labeling, including prescribing information, patient labeling, and carton/container labeling, that incorporates certain statements required by section 506(h). The document defines the limited population pathway for antibacterial and antifungal drugs (LPAD pathway) and its relationship to other programs. It also details the pathway process and considerations for approval.