1. 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
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
