1. Microdose radiopharmaceutical diagnostic drugs: nonclinical study recommendations Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018 Subject(s): Drug Evaluation, PreclinicalRadiopharmaceuticals -- administration & dosageRadiopharmaceuticals -- pharmacokineticsDiagnostic ImagingDiagnostic Uses of ChemicalsRadiopharmaceuticals -- toxicityHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, December 5, 2017 Subject(s): Computer-Aided Design -- standardsDevice ApprovalManufactured Materials -- standardsMaterials Testing -- standardsPrinting, Three-Dimensional -- standardsQuality ControlComputer Security -- standardsDiagnostic ImagingModels, AnatomicProduct Labeling -- standardsReproducibility of ResultsSoftware -- standardsSterilization -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
