FDA advances new GMP (good manufacturing practice) rules for PET (positron emission tomography) radiopharma firms
This article was originally published in Clinica
The US FDA is seeking comment on its proposed rule on current good manufacturing practice (GMP) for entities that make the radiopharmaceuticals used for positron emission tomography (PET). The revised preliminary draft proposal incorporates comments FDA received at a 1999 public meeting. Along with the proposed rule, the FDA is also issuing a companion proposed guidance document.