Committee Mission
The task force will be involved in all aspects of regulatory engagement with federal and state agencies including, but not limited to, FDA, CMS, and NRC. It will also be involved in policy development and education regarding regulations and inspections as the field grows in these new areas, as well as enhancing regulations in long standing areas of PET and SPECT.
Committee Charges
- To optimize evidentiary requirements for the approval of new radiotracers.
- To optimize evidentiary requirements for the approval of radiotherapeutics.
- To engage FDA in dialogue on SNMMI’s recommendations of possible pathways to improving the review and approval process.
- To improve clinical access and reimbursement for non-approved radiolabeled agents under development (traditional IND) or under an Expanded Access IND.
- To ensure proper training of professionals delivering radiopharmaceuticals.
- To educate and ensure inspections are following the designated guidance.
- To ensure guidance is clear and provides access and safety.