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Start Over Subjects United States. Department of Health and Human Services ✖Remove constraint Subjects: United States. Department of Health and Human Services Subjects United States. Food and Drug Administration ✖Remove constraint Subjects: United States. Food and Drug Administration

21. 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

24. 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

26. 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

27. 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

30. Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, December 2020
Subject(s):
Correspondence as Topic
Drug Approval
Drug Industry
Facility Regulation and Control
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration