Guidance for Industry on Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products-Chemistry, Manufacturing, and Controls Documentation; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation." This document provides guidance for industry on the chemistry, manufacturing, and controls documentation that should be submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nasal spray and inhalation solution, suspension, and spray drug products intended for local and/or systemic effect. The guidance also provides recommendations on labeling.