The FDA has issued a revised draft guidance, “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations.”
The agency is requesting for written comments to be submitted within 90 days to the Division of Dockets Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The agency advises that all comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. Electronic comments can be submitted to www.regulations.gov.
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). The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.”
View the revised draft guidance.