The FDA has issued a revised draft guidance, “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations.” The guidance is scheduled for publication in the Federal Register on April 19, 2018; comments regarding the document should be submitted to the FDA within 60 days of publication.
According to a draft of the Federal Register notice, “The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers, or MDIs) and inhalation powders (also known as dry powder inhalers, or DPIs). Although not explicitly discussed, some of the principles and recommendations provided in this guidance may be applicable to nasal delivery products, as well. The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.”
A separate FDA announcement said, “Quality and product performance are particularly important for the potentially life-threatening conditions that these complex products are used to treat. The information in the guidance will benefit applicants by providing clarity with respect to product development and information to submit in an application. The guidance document’s focus on critical quality attributes can help foster a more transparent and consistent approach to product development, with improved performance that is better tailored to address consumer needs.”
View the revised draft guidance.
