PETNet Solutions, Cardinal Health, and IBA Molecular have provided the SNM's Clinical Trials Network with access to FDA drug master files for F-18-3'-deoxy-3'-fluorothymidine. The move could streamline drug discovery by integrating imaging biomarkers into multicenter clinical trials.
"They have provided us with letters of cross-reference that will allow FLT clinical trial sites to obtain investigational imaging agents from a commercial provider," said incoming SNM president and cochair of the network Dr. Michael M. Graham.
Researchers must demonstrate their radiopharmaceutical agent meets FDA standards to get approval. Sites will now have the option to purchase FLT from these pharmaceutical companies, all of which have drug master files stored with the FDA.
