NorthStar Medical Radioisotopes, LLC: TechneGen Generator

There are multiple deficiencies in the product labeling, including the user manuals, training materials and package insert related to instructions for preparation and safe use of the TechneGen system.

These deficiencies have prevented the full evaluation of the safety of the TechneGen generator system.

Please refer to the meeting minutes from our teleconference on July 17, 2013, for a detailed discussion of these issues and for our recommendations on how to revise the user manuals and training materials and how to design and conduct a human factor testing study to provide meaningful data to support the safe use of the generator.

2. The application lacks data sufficient to support the ability of the proposed TechneGen system to remain in a state of microbiological control over the © in-use period.

The valves are highly unlikely to be dried completely with the © and this seems consistent with your observation that the tubing connections can retain liquid droplets after a. Additionally, you will need to address the risks posed by the possibility of leaking connections and encrusted connections cited in the labeling, and develop a procedure required to assess and correct these malfunctions.

The sterilizing filter should be integrity tested prior to release of the drug product.

You will need to describe the test method and acceptance criteria in the application and the labeling.

Be advised that any change would require submission of complete chemistry, manufacturing and controls information (including the stability data) for that solution.

Clarify how this will be addressed in the labeling.

14. You have indicated that the drug product post-approval stability protocol will be performed on one lot annually using the largest Mo99 source size at a designated nuclear pharmacy or an authorized testing laboratory.

17. Your application referenced the Drug Master File (DMF) 26592. This DMF was found inadequate to support your submission and a deficiency letter was sent to the DMF holder on October 10, 2013. These deficiencies must be adequately addressed before this application can be approved.