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FDA finalises guidance, ‘Limited Population Pathway for Antibacterial and Antifungal Drugs’

This guidance is intended to assist sponsors in developing labelling, including prescribing information, patient labelling, and carton/container labelling for drugs approved under the LPAD pathway

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The US Food and Drug Administration is finalising guidance for industry titled, “Limited Population Pathway for Antibacterial and Antifungal Drugs.” The final guidance will aid in the development of certain new antibacterial and antifungal drugs by describing criteria, processes, and other general considerations required of drugs approved under the limited population pathway for antibacterial and antifungal drugs (LPAD pathway).

This guidance is intended to assist sponsors in developing labelling, including prescribing information, patient labelling, and carton/container labelling for drugs approved under the LPAD pathway. In addition to soliciting public comment on the draft guidance via a docket, FDA held an open public meeting on July 12, 2019, to receive input from the scientific community. Comments and feedback provided at that meeting and from the open public docket were considered by the agency in finalising the guidance.

The LPAD pathway was created by the 21st Century Cures Act (Cures Act). The LPAD pathway builds on ongoing efforts to spur drug development in this area by facilitating the development and approval of antibacterial and antifungal drugs intended to treat serious or life-threatening infections in a limited population of patients with unmet needs. In certain circumstances, the LPAD pathway is an important tool enabling the FDA to conclude that the benefits of a drug outweigh its risks in the intended limited population.

To date, two drugs, Arikayce and Pretomanid, have been approved under the LPAD pathway.

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