1. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3) Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2017 Subject(s): Arrhythmias, Cardiac -- chemically inducedArrhythmias, Cardiac -- diagnosisCardiac Electrophysiology -- methodsCardiac Electrophysiology -- standardsDrug ApprovalElectrocardiography -- standardsLong QT Syndrome -- chemically inducedCardiotoxinsClinical Trials as TopicCongresses as TopicDiagnosis, Computer-AssistedDrug-Related Side Effects and Adverse ReactionsInternational CooperationPharmaceutical Preparations -- administration & dosageReference StandardsResearch DesignSex FactorsHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017 Subject(s): Device ApprovalPapillomavirus Infections -- diagnosisReagent Kits, Diagnostic -- standardsCervix Uteri -- cytologyCervix Uteri -- virologyEquipment FailureEquipment SafetyGenotyping Techniques -- standardsMass ScreeningPapillomaviridae -- classificationPapillomaviridae -- geneticsQuality ControlReference StandardsReproducibility of ResultsResearch DesignSpecimen HandlingHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.