SPL for Positronic Emission Tomography (PET) Drugs
Training slides


Links to SPL templates for the three drugs (fludeoxyglucose F18, Ammonia N13, Sodium fluoride F18):
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm241316.htm

If you are likely to be submitting an NDA or ANDA for these drugs, you may want to attend a training session on the creation of SPL for these. A session has been set up on March 8, from 1 to 2:30. To register, contact spl@fda.hhs.gov and provide first & last name of attendee, and organization. Webinar connections are limited.

Draft Guidance:
PET Drug Applications — Content and Format for NDAs and ANDAs [Fludeoxyglucose F 18 Injection; Ammonia N 13 Injection; Sodium Fluoride F 18 Injection]
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078738.pdf

Links to sample 356h forms, CMC sections:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm