PetNet to supply SNM clinical trial network
PetNet Solutions, a wholly owned subsidiary of Siemens Healthcare, has become a registered supplier of investigational F-18 fluorothymidine (F-18 FLT) to the Society of Nuclear Medicine's (SNM) Clinical Trial network.
Becoming a supplier was made possible via a cross reference from Siemens Molecular Imaging/PetNet's drug master file (DMF) to the SNM's centralized investigational new drug (IND), according to the Knoxville, Tenn.-based PetNet.
The company said that in addition to the National Cancer Institute's (NCI) previous filing of a cross-reference letter of the same Type II DMF that Siemens submitted to the FDA for its investigational F-18 FLT. The cross reference allows F-18 FLT to be produced and used by any principle investigator in an NCI or SNM multi-center clinical trial.
The imaging biomarker will also be available to investigators outside of the NCI and SNM trials, if they receive independent FDA approval of an IND or appropriate approval, such as a local Radioactive Drug Research Committee approval, PetNet said.
Becoming a supplier was made possible via a cross reference from Siemens Molecular Imaging/PetNet's drug master file (DMF) to the SNM's centralized investigational new drug (IND), according to the Knoxville, Tenn.-based PetNet.
The company said that in addition to the National Cancer Institute's (NCI) previous filing of a cross-reference letter of the same Type II DMF that Siemens submitted to the FDA for its investigational F-18 FLT. The cross reference allows F-18 FLT to be produced and used by any principle investigator in an NCI or SNM multi-center clinical trial.
The imaging biomarker will also be available to investigators outside of the NCI and SNM trials, if they receive independent FDA approval of an IND or appropriate approval, such as a local Radioactive Drug Research Committee approval, PetNet said.