- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-1098.