The Food and Drug Administration (FDA) issued guidance for industry entitled “PET Drug Applications – Content and Format for NDAs and ANDAs.”
The guidance is intended to assist the manufacturers of certain PET drugs – FDG, ammonia N 13, and sodium fluoride F 18 – in submitting NDAs and ANDAs in accordance with FDA regulations. In order to continue to market PET drugs for clinical use, manufacturers must submit NDAs or ANDAs by December 12, 2011.
In addition to the guidance for filing the applications, FDA has provided sample formats for the Chemistry, Manufacturing, and Controls (CMS) section.
To view the final guidance, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078738.pdf
To view the sample formats for the CMC section, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078740.pdf