The FDA has announced the availability of a draft guidance document entitled, “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs”.
The draft guidance is intended to assist manufacturers of PET drugs in submitting investigational new drug applications (INDs). The draft guidance summarizes the IND process for PET drugs, makes recommendations for how to submit an IND, provides advice on expanded access options for investigational PET drugs, and describes the process for requesting permission to charge for an investigational PET drug.
Comments will be accepted until May 14, 2012 and may be submitted in writing or electronically through http://www.regulations.gov (Search Docket No. FDA-2012-D-0081).
To view the draft guidance: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291573.pdf