Draft Guidance for Industry on Integration of Dose-Counting Mechanisms Into MDI Drug Products; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Integration of Dose-Counting Mechanisms into MDI Drug Products." This draft guidance makes recommendations to manufacturers to incorporate dose-counters into metered-dose inhalers (MDIs) being developed for the treatment of lung diseases. The recommendations made in this draft guidance are intended to enhance the use of MDIs, specifically to help patients identify when MDIs are no longer delivering reliable doses.