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Integration of Dose-Counting Mechanisms into MDI Drug Products March 2003


Integration of Dose-Counting Mechanisms into MDI Drug Products

Issued by:
Guidance Issuing Office
Center 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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.