1. Delays in confirmatory trials for drug applications granted FDA’s accelerated approval raise concerns Publication: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2022 Subject(s): Drug ApprovalLegislation, DrugUnited StatesUnited States. Food and Drug Administration
2. Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023 Subject(s): Antibodies, MonoclonalCOVID-19 Drug TreatmentDrug ApprovalDrug IndustryGovernment RegulationLegislation, DrugSARS-CoV-2United States
