Limited Population Pathway for Antibacterial and Antifungal Drugs; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Limited Population Pathway for Antibacterial and Antifungal Drugs." This guidance provides information on the implementation of the limited population pathway provision of the 21st Century Cures Act (Cures Act), which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). This guidance finalizes the draft guidance of the same name issued on June 13, 2018.