Subjects: COVID-19 -- drug therapy - Digital Collections - National Library of Medicine Search Results

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1. 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 investigators

Publication:: [Silver Spring, MD] : Oncology Center of Excellence, June 2020
Subject(s):: Biological Products -- therapeutic use
COVID-19 -- drug therapy
Drugs, Investigational
Ethics Committees, Research
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. COVID-19: developing drugs and biological products for treatment or prevention

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2021
Subject(s):: Biological Products
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Drug Industry
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
Subject(s):: Biological Products
COVID-19 -- drug therapy
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. 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, Monoclonal
COVID-19 -- drug therapy
Enzyme-Linked Immunosorbent Assay
SARS-CoV-2
Viral Plaque Assay
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. COVID-19: master protocols evaluating drugs and biological products for treatment or prevention

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Biological Products
Clinical Trial Protocols as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. Alternative policies for pricing novel vaccines and drug therapies for COVID-19

Author(s):: Emond, Sarah K., author
Pearson, Steven D., author
Publication:: [Boston, Massachusetts] : Institute for Clinical and Economic Review, July 1, 2020
Subject(s):: COVID-19 -- drug therapy
COVID-19 Vaccines -- economics
United States