Limited population pathway for antimicrobial and antifungal drugs (LPAD)

A US regulatory pathway designed to accelerate the availability of new treatments for serious and life-threatening infections in a limited population of patients with unmet needs.

For products approved through this pathway, product labelling and promotional material must make it clear the populations in which the product has been tested. Such materials must also highlight the greater uncertainty or higher risk that these patients face because of the accelerated appraisal process.

LPAD was introduced in the 21^st Century Cures Act, signed into law in 2016. In 2019, approval through this pathway was given for use of pretomanid to treat drug-resistant tuberculosis.

Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry (FDA, 2020)

Limited Population Pathway for Antibacterial and Antifungal Drugs – the LPAD Pathway (FDA, 2020)

Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics (FDA, 2014)