Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations April 2018

Not for implementation. Contains non-binding recommendations.

Docket Number: FDA-2018-D-1098 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research

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.

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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2018-D-1098.