1. Patient-focused drug development: collecting comprehensive and representative input : guidance for industry, Food and Drug Administration staff, and other stakeholders Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020 Subject(s): Drug DevelopmentFeedbackSampling StudiesPatient Reported Outcome MeasuresUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. 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
