At the recent RDD 2018 event in Arizona, the FDA issued revised draft guidance for MDI and DPI quality considerations. The guidance, entitled ‘Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations’ is available for comment for a period of 90 days.
The purpose of the draft guidance document is to provide recommendations to the industry on the development and manufacture of inhalation aerosols; also known as metered dose inhalers or MDIs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 FDA are requesting written comments to be submitted within 90 days to:
The Division of Dockets Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane
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.
Novi are currently in the process of reviewing the draft guidance to formulate a response.