Cyclomedica Australia Pty Ltd.: Technegas™ Technetium Tc-99m carbon aerosol

Food, Drug, and Cosmetic Act for Technegas™ Technetium Tc-99m carbon aerosol.

We acknowledge receipt of your major amendment dated February 26, 2021, which extended the goal date by three months to June 26, 2021.

You have not established aerosol critical quality attributes and specifications to ensure the identity, strength, quality, purity, or potency of the drug product under 21 CFR 314.50(d) (ii)((a)).

For example, Jérémie Pourchez etal, Generation and characterization of radiolabeled nanosized carbonaceous aerosols for human inhalation studies, Journal of Aerosol Science, Elsevier,2013,55, pp.1-11.

2012.07.011. For each method, submit the analytical method description and the method validation.

Provide updated test reports, address test observations, detailed corrective actions with any proposed packaging design changes for primary and secondary packaging for review and approval.

Therefore, you will need to include the following information in your complete response:

Also note our recommendation to cover the to-be-marketed range of sodium pertechnetate Tc 99m loadings from minimum to maximum when conducting new CMC investigation under CMC Issue #1.

CMC investigation under Product Quality Issue #1.