1. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017 Subject(s): Equipment and SuppliesEquipment SafetyEvidence-Based MedicineProduct Surveillance, PostmarketingData CollectionData Interpretation, StatisticalDecision MakingDevice ApprovalQuality ControlHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Real-world data: assessing registries to support regulatory decision-making for drug and biological products : guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023 Subject(s): Biological ProductsData CollectionDecision MakingDrug IndustryLegislation, DrugGovernment RegulationPharmaceutical PreparationsRegistriesUnited States
