New Draft Guidance for Industry: Limited Population Pathway for Antibacterial and Antifungal Drugs

FDA is announcing the availability of a draft guidance for industry entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.”  Section 506(h)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(h)(5)) requires FDA to issue guidance “describing criteria, processes, and other general considerations for demonstrating the safety and effectiveness of limited population antibacterial and antifungal drugs.”  This guidance provides this information and is intended to assist sponsors in the development of certain new antibacterial and antifungal drugs for approval under the LPAD pathway.  This guidance also is intended to assist sponsors in developing labeling, including prescribing information, patient labeling, and carton/container labeling, that incorporates certain statements required by section 506(h) of the FD&C Act, added by section 3042 of the Cures Act.  This guidance satisfies the requirements under section 506(h)(5) of the FD&C Act.

The LPAD pathway is intended to encourage the development of certain antibacterial and antifungal drugs to help address the critical public health and patient care concern that has resulted from the current decline in antibacterial drug research and development as serious antibacterial and antifungal drug-resistant infections increase.  FDA is committed to using the tools at its disposal, including the LPAD pathway, to help encourage the development of safe and effective drug products that address unmet needs of patients with serious bacterial and fungal infections.