Docket Management
Docket: 01D-0510 - Draft Guidance on Integration of Dose-Counting Mechanisms into MDI Drug Products
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. Jenny Peters Date/Time 2002-02-11 16:51:55
Organization Global Regulatory Affairs; Pharmacia Corp
Category Company

Comments for FDA General
1. General Comments We have reviewed the Guidance for Industry, Integration of Dose-Counting Mechanisms into MDI Drug Products, November 2001, and would like to offer the following comments. General: The industry has been trying to develop dose-counting mechanisms for MDI for a number of years now but there is no simple technical solution available today which can effectively measure the number of doses. We can therefore not support the issuance of a guideline to this intended effect at the current technical stage and would argue that the existing practice be continued until such device is available, i.e. recommending the float method to be used to control the dose usage. III B Reliability Issues: “The reliability of dose-counters should be established during development under in-vitro testing (simulating use and potential abuse), as well as in clinical use studies that are designed and conducted to obtain information on the technical function and the perceived utility for patients of the counters in actual use.” We believe the utility of the dose counters should be documented by in vitro studies only. The indication to conduct clinical studies for this purpose poses an unnecessary regulatory burden that does not add to the quality and/or safety of the counting device in proportion to the added cost and effort.

EC -1