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Start Over Subjects COVID-19 ✖Remove constraint Subjects: COVID-19 Subjects United States. Department of Health and Human Services ✖Remove constraint Subjects: United States. Department of Health and Human Services

1. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021
Subject(s):
Clinical Trial Protocols as Topic
Clinical Trials as Topic -- methods
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Notifying CDRH of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act during the COVID-19 public health emergency (revised): guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, November 2020
Subject(s):
Equipment and Supplies
Manufacturing Industry
Medical Device Legislation
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. 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

6. 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

7. 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

8. Hospital experiences responding to the COVID-19 pandemic: results of a national pulse survey March 23–27, 2020

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, April 2020
Subject(s):
COVID-19
Disaster Planning -- organization & administration
Government Regulation
Hospitals -- supply & distribution
Surge Capacity -- statistics & numerical data
United States
United States. Department of Health and Human Services