A submission for a diabetic testing agent (i.e., blood glucose strip) undergoes a similar review process as a drug product, although the manufacturer must satisfy a different set of requirements to be considered for reimbursement according to the Maximum Allowable Reimbursement (MAR) mechanism and pricing schedule.

A Committee to Evaluate Drugs (CED) consultant reviews the submission first. As with drug products, the CED as a whole is asked to make a final recommendation to the Executive Officer regarding the reimbursement of diabetic testing agents. Please refer to section IX of the Formulary for more information on MAR and to Part II: Drug Submission Review Process for more detail on the review process.

The Submission Guidelines for Diabetic Testing Agents contains the following information :

• Submission Requirements
• Points of Clarification
• Format and Organization of Submissions

Pharmaceutical manufacturers should refer to this web site for any future updates to the Submission Guidelines for Diabetic Testing Agents.