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1321. 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

1322. 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

1323. Product labeling for laparoscopic power morcellators: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 30, 2020
Subject(s):: Laparoscopy
Morcellation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1324. 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

1325. 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

1326. Medicaid providers: CMS oversight should ensure state implementation of screening and enrollment requirements : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, October 2019
Subject(s):: Government Regulation
Health Personnel
Medicaid -- standards
United States
Centers for Medicare & Medicaid Services (U.S.)

1327. 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.)

1328. Organ transplants: changes in allocation policies for donated livers and lungs : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, October 2020
Subject(s):: Government Regulation
Health Care Rationing -- organization & administration
Healthcare Disparities
Liver Transplantation -- economics
Lung Transplantation -- economics
United States

1329. Prescription drugs: Department of Veterans Affairs paid about half as much as Medicare Part D for selected drugs in 2017 : report to the Ranking Member, Committee on the Budget, U.S. Senate

Publication:: Washington, DC : United States Government Accountability Office, December 2020
Subject(s):: Costs and Cost Analysis -- statistics & numerical data
Drug Costs -- statistics & numerical data
Government Regulation
Medicare Part D -- economics
United States
United States. Department of Veterans Affairs

1330. Medicaid: data completeness and accuracy have improved, though not all standards have been met : report to Congressional addressees

Publication:: Washington, DC : United States Government Accountability Office, January 2021
Subject(s):: Government Regulation
Medicaid -- statistics & numerical data
United States
Centers for Medicare & Medicaid Services (U.S.)

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