On Tuesday, December 4, 2012, the Food and Drug Administration announced the availability of a guidance entitled, “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.” This guidance will support manufacturers of PET drugs in submitting investigational new drug applications (INDs).
For the complete Federal Register notice, please click on the following:
http://www.gpo.gov/fdsys/pkg/FR-2012-12-04/html/2012-29163.htm