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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 Treatment
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 Treatment
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 Treatment
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 Treatment
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 Treatment
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 Treatment
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 Treatment
COVID-19 Vaccines -- economics
United States

8. Understanding coverage considerations for COVID-19 vaccines and treatments

Author(s):

Beleche, Trinidad, author
Bush, Laina, author
Finegold, Kenneth, 1957- author
Manocchio, Teresa, author
Pyda, Sarada, author
Samson, Lok Wong, author
Sommers, Benjamin D., author

Publication:

Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, May 2023

Subject(s):

Cost Savings
COVID-19 Drug Treatment
COVID-19 -- economics
COVID-19 Vaccines -- economics
Insurance Coverage
United States

9. Special assessment of outpatient treatments for COVID-19: nirmatrelvir/ritonavir (Paxlovid) health-benefit price benchmark update

Author(s):

Whittington, Melanie D., author
Campbell, Jonathan D., author
Richardson, Marina, author
Nhan, Emily, author
McKenna, Avery, author
Agboola, Foluso, author
Pearson, Steven D., author

Publication:

[Boston, Massachusetts] : Institute for Clinical and Economic Review, December 20, 2022

Subject(s):

Ambulatory Care -- economics
Antiviral Agents -- economics
COVID-19 Drug Treatment
Drug Combinations
Drug Costs
Lactams
Leucine
Nitriles
Proline
Ritonavir
United States

10. Understanding coverage considerations for COVID-19 vaccines and treatments

Author(s):

Beleche, Trinidad, author
Bush, Laina, author
Finegold, Kenneth, 1957- author
Manocchio, Teresa, author
Pyda, Sarada, author
Samsom, Lok Wong, author
Sommers, Benjamin D., author

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, August 2022

Subject(s):

Cost Savings
COVID-19 -- economics
COVID-19 Drug Treatment
COVID-19 Vaccines -- economics
Insurance Coverage -- economics
Drug Approval
United States