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Titles
- Understanding coverage considerations for COVID-19 vaccines and treatments2
- Alternative policies for pricing novel vaccines and drug therapies for COVID-191
- Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment1
- COVID-19 antivirals utilization: geographic and demographic patterns of treatment in 20221
- COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators1
- COVID-19: developing drugs and biological products for treatment or prevention1
- COVID-19: master protocols evaluating drugs and biological products for treatment or prevention1
- COVID-19: potency assay considerations for monoclonal antibodies and other therapeutic proteins targeting SARS-CoV-2 infectivity1
- Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry1
- Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators1
- Special assessment of outpatient treatments for COVID-19: final evidence report and meeting summary1
- Special assessment of outpatient treatments for COVID-19: nirmatrelvir/ritonavir (Paxlovid) health-benefit price benchmark update1
- Variation in use of anti-SARS-CoV-2 monoclonal antibody therapies by social vulnerability and urbanicity1