1. Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies: guidance for industry, investigators, and institutional review boards Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023 Subject(s): Clinical Trials as TopicDisastersEmergenciesGovernment RegulationPublic HealthUnited States
2. 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.
3. Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023 Subject(s): Clinical Trials as TopicDrug DevelopmentDrug IndustryGovernment RegulationOutcome Assessment, Health CareUnited States
4. Submitting patient-reported outcome data in cancer clinical trials: guidance for industry : technical specifications document Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023 Subject(s): Clinical Trials as TopicDrug DevelopmentDrug IndustryGovernment RegulationNeoplasms -- drug therapyPatient Reported Outcome MeasuresUnited States
