1. Antimicrobial susceptibility test (AST) system devices: updating breakpoints in device labeling : guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2023 Subject(s): Government RegulationMedical Device LegislationMicrobial Sensitivity Tests -- standardsProduct LabelingUnited States
2. Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2023 Subject(s): Biological Products -- administration & dosageDrug Dosage CalculationsDrug IndustryDrug LabelingDrug PackagingGovernment RegulationInjections -- standardsPrescription Drugs -- administration & dosageProduct LabelingProduct PackagingUnited States
