FDA Issues Recommendations on Limited Population Pathway for Antimicrobials

The FDA released draft guidance for sponsors who want to use the agency’s limited population pathway for antibacterial and antifungal drugs.

The agency said it can approve an antibacterial or antifungal drug, alone or with other drugs under the LPAD pathway if it is intended to treat a serious or life-threatening infection in a limited population of patients with unmet needs and if it meets the approval standards under the Food, Drug and Cosmetic Act or the licensure standards in the Public Health Service Act.

Product development timelines can be reduced through frequent communications with the agency in early development for sponsors interested in LPAD pathway approval. The agency may be able to offer advice on the product’s potential eligibility early in clinical development depending on the proposed development program and clinical data.