Issue Date: August 5, 2020
Issued by: Center for Biologics Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry
This guidance provides information on the implementation of section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 3042 of the 21st Century Cures Act, which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway).
Download the Guidance Document
