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2942. 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

2943. 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

2945. 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

2946. 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

2948. Medicaid: CMS needs more information on states' financing and payment arrangements to improve oversight : report to the Chairman, Committee on Homeland Security and Governmental Affairs, U.S. Senate

Publication:
Washington, DC : United States Government Accountability Office, December 2020
Subject(s):
Financing, Government -- organization & administration
Government Regulation
Medicaid -- economics
United States
Centers for Medicare & Medicaid Services (U.S.)