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# FDA Inhaler Draft Guidance
- URL: https://www.fdaweb.com/fda-inhaler-draft-guidance/
- Published: 2018-04-18T12:00:00.000Z
- Updated: 2026-09-14T23:59:41.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5141246

FDA says a draft guidance, *Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality Considerations*, is available. A 4/19 *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-08200.pdf?ref=fdaweb.com) says the [guidance’s](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070573.pdf?ref=fdaweb.com) purpose is to provide recommendations to industry in the development and manufacture of inhalation aerosols.

The draft describes points to consider to help ensure product quality and performance for MDIs and DPIs. It includes chemistry, manufacturing, and controls information recommended for inclusion in NDAs and ANDAs. And it contains recommendations on certain aspects of labeling for NDA and ANDA MDI and DPI products.

The guidance revises an 11/13/98 draft guidance on the same topic.