Draft Guidance for Industry on Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation.'' This draft document provides guidance for industry on the chemistry, manufacturing, and controls (CMC) documentation to be submitted in new drug applications (NDA's) and abbreviated new drug applications (ANDA's) for metered dose inhalation aerosols, metered dose nasal aerosols, and inhalation powders.