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