Harmonization of Quality Attributes for IND Submissions

Objectives: he FDA is looking forward to harmonizing the Chemistry, Manufacturing and Controls protocols for PET IND submissions. It is critical that the radio tracers administered to the patients are safe with similar quality attributes. This is an effort to harmonize various protocols from different sponsors so that the patients administered with the same radio tracer(s) have the same quality. This presentation will focus on the various sections of the CMC submissions including drug substance, precursor, manufacturing information, quality, and stability of the radiolabeled drug product.