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. Benefit-risk assessment for new drug and biological products: guidance for industry Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023 Subject(s): Biological ProductsDrug ApprovalDrug IndustryDrugs, InvestigationalGovernment RegulationPharmaceutical PreparationsRisk AssessmentUnited States
3. Real-time oncology review (RTOR): guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2023 Subject(s): Biological ProductsDrug ApprovalDrug IndustryDrugs, InvestigationalGovernment RegulationNeoplasms -- drug therapyUnited States
