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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance is intended to assist manufacturers who are developing or plan to develop drug products for oral inhalation using metered-dose inhalers (MDIs). The guidance reflects the Agency's current recommendations regarding the integration of dose-counting mechanisms into MDI drug products for oral inhalation. Although the contents of the guidance should be considered by any manufacturer of any MDI drug product (including nasal MDI products), this guidance is not specifically intended for manufacturers of already marketed MDI drug products for oral inhalation nor for manufacturers developing MDIs for other routes of administration (e.g., nasal MDIs). It is also not intended for manufacturers developing multidose dry powder inhalers (MDPIs), which already incorporate dose counters as an integral part of the delivery system. Manufacturers developing new MDPIs are encouraged to continue including dose counters in their products and may find the contents of this guidance useful in their planning.
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-2003-D-0285.