1. COVID-19: potency assay considerations for monoclonal antibodies and other therapeutic proteins targeting SARS-CoV-2 infectivity Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021 Subject(s): Antibodies, MonoclonalCOVID-19 -- drug therapyEnzyme-Linked Immunosorbent AssaySARS-CoV-2Viral Plaque AssayUnited StatesUnited States. Department of Health and Human ServicesUnited 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
