1. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023 Subject(s): Biological ProductsClinical Trials as TopicData AnalysisDecision MakingDrug ApprovalDrug IndustryDrug and Narcotic ControlGovernment RegulationUnited StatesUnited States.
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
