1. Development and licensure of vaccines to prevent COVID-19: guidance for industry Publication: [Silver Spring, MD] : Center for Biologics Evaluation and Research, October 2023 Subject(s): COVID-19 Vaccines -- standardsDrug DevelopmentDrug IndustryGovernment RegulationVaccine DevelopmentUnited States
2. 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
3. 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
4. Rare diseases: considerations for the development of drugs and biological products : guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023 Subject(s): Biological ProductsDrug DevelopmentDrug IndustryGovernment RegulationRare Diseases -- drug therapyUnited States