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3042. 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

3045. Mouse embryo assay for assisted reproduction technology devices: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, January 5, 2021
Subject(s):
Biological Assay
Device Approval
Embryo, Mammalian
Mice
Reproductive Techniques, Assisted
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3047. Effects of the COVID-19 public health emergency on formal meetings and user fee applications for medical devices: questions and answers (revised) : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, June 2020
Subject(s):
Device Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3048. Enforcement policy for the Quality Standards of the Mammography Quality Standards Act during the COVID-19 public health emergency: guidance for mammography facilities, state MQSA contract partners, FDA approved MQSA accreditation bodies, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 2020
Subject(s):
Facility Regulation and Control
Mammography -- standards
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3050. Providing regulatory submissions in electronic format: content of the risk evaluation and mitigation strategies document using structured product labeling

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):
Drug Approval
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration