Fillable PET Drug Applications Content and Format for NDAs and ANDAs - fda

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Guidance PET Drug Applications -- Content and Format for NDAs and ANDAs Fludeoxyglucose F 18 Injection Ammonia N 13 Injection Sodium Fluoride F 18 Injection U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2011 Procedural Guidance PET Drug Applications -- Content and Format for NDAs and ANDAs Fludeoxyglucose F 18 Injection Ammonia N 13...
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