1. 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
2. Digital health technologies for remote data acquisition in clinical investigations: guidance for industry, investigators, and other stakeholders Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023 Subject(s): Data CollectionDigital HealthEquipment DesignEquipment SafetyGovernment RegulationMedical Device LegislationRemote Sensing Technology -- standardsUnited States
