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2. Testing of glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution, and other high-risk drug components for diethylene glycol and ethylene glycol: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):
Drug Contamination
Drug Industry
Drug-Related Side Effects and Adverse Reactions
Ethylene Glycols
Glycerol
Government Regulation
Propylene Glycol
Sorbitol
United States

8. Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, March 30, 2023
Subject(s):
Computer Security -- legislation & jurisprudence
Device Approval
Equipment Safety
Government Regulation
United States
United States.

11. Transition plan for medical devices that fall within enforcement policies issued during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry, other stakeholders, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 27, 2023
Subject(s):
Equipment and Supplies
Government Regulation
Medical Device Legislation
COVID-19
United States
United States. Food and Drug Administration

12. Transition plan for medical devices issued emergency use authorizations (EUAs) related to coronavirus disease 2019 (COVID-19): guidance for industry, other stakeholders, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 27, 2023
Subject(s):
Equipment and Supplies
Government Regulation
Medical Device Legislation
COVID-19
United States
United States. Food and Drug Administration

13. Enforcement policy for face masks and barrier face coverings during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 13, 2023
Subject(s):
COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
Personal Protective Equipment
United States
United States. Food and Drug Administration

14. Enforcement policy for face shields, surgical masks, and respirators during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 13, 2023
Subject(s):
COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
N95 Respirators -- standards
Personal Protective Equipment
Respiratory Protective Devices -- standards
United States
United States. Food and Drug Administration

18. Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2023
Subject(s):
Administration, Oral
Drug Compounding -- methods
Drug Compounding -- standards
Drug Industry
Government Regulation
Ibuprofen
Legislation, Drug
Suspensions
United States
United States. Food and Drug Administration
United States.

26. Long-term projections of health care spending and the implications for the federal budget: presentation at the 15th annual meeting of the OECD’s working party of parliamentary budget officials and independent fiscal institutions

Author(s):
Topoleski, Julie H., author
Publication:
[Washington, D.C.] : Congressional Budget Office, April 13, 2023
Subject(s):
Budgets -- trends
Federal Government
Forecasting
Health Care Costs -- trends
Health Expenditures -- trends
United States
Organisation for Economic Co-operation and Development.

31. Budgetary effects of policies to modify or eliminate Medicaid’s institutions for mental diseases exclusion

Author(s):
Duchovny, Noelia Judith, author
Hammond, Stuart, (Of Congressional Budget Office), author
Mutter, Ryan, 1976- author
Publication:
[Washington, D.C.] : Congressional Budget Office, April 2023
Subject(s):
Budgets
Federal Government
Health Expenditures -- statistics & numerical data
Medicaid -- economics
Mental Health Services -- economics
State Government
United States

33. Non-clinical performance assessment of tissue containment systems used during power morcellation procedures: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 26, 2023
Subject(s):
Device Approval
Government Regulation
Morcellation -- instrumentation
Morcellation -- legislation & jurisprudence
Morcellation -- standards
United States

35. Implementation of acceptable full-length and abbreviated donor history questionnaires and accompanying materials for use in screening donors of blood and blood components: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, May 2023
Subject(s):
Blood Donation
Blood Donors
Donor Selection
Government Regulation
Mandatory Testing
Surveys and Questionnaires
United States

36. Recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of human immunodeficiency virus transmission by blood and blood products: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, May 2023
Subject(s):
Blood Donation
Blood Donors
Blood Transfusion
Donor Selection
Government Regulation
HIV Infections -- prevention & control
Mandatory Testing
United States

38. Presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):
Direct-to-Consumer Advertising -- legislation & jurisprudence
Direct-to-Consumer Advertising -- standards
Disclosure
Drug Industry
Drug Labeling -- legislation & jurisprudence
Drug Labeling -- standards
Government Regulation
United States

39. Alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, June 2023
Subject(s):
Biological Products -- standards
Blood Platelets
Government Regulation
Platelet Transfusion
Refrigeration
United States

42. Hydrogen peroxide-based contact lens care products: consumer labeling recommendations : premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, July 27, 2023
Subject(s):
Contact Lens Solutions
Device Approval
Government Regulation
Hydrogen Peroxide
Product Labeling
United States
United States. Food and Drug Administration

44. M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
Subject(s):
Carcinogens
Drug Contamination -- prevention & control
Drug Development
Drug Industry
Government Regulation
Mutagenicity Tests
Mutagens
United States
United States. Food and Drug Administration

45. Understanding coverage considerations for COVID-19 vaccines and treatments

Author(s):
Beleche, Trinidad, author
Bush, Laina, author
Finegold, Kenneth, 1957- author
Manocchio, Teresa, author
Pyda, Sarada, author
Samson, Lok Wong, author
Sommers, Benjamin D., author
Publication:
Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, May 2023
Subject(s):
Cost Savings
COVID-19 Drug Treatment
COVID-19 -- economics
COVID-19 Vaccines -- economics
Insurance Coverage
United States

46. Updated national survey trends in telehealth utilization and modality (2021-2022)

Author(s):
Lee, Euny C., author
Grigorescu, Violanda, author
Enogieru, Idia, author
Smith, Scott R., author
Samson, Lok Wong, author
Conmy, Ann B., author
De Lew, Nancy, author
Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, April 19, 2023
Subject(s):
Facilities and Services Utilization -- statistics & numerical data
Telemedicine -- statistics & numerical data
Telemedicine -- trends
Videoconferencing -- statistics & numerical data
Videoconferencing -- trends
United States

47. Social needs screening among non-federal acute care hospitals, 2022

Author(s):
Chang, Wei, (Of United States. Department of Health and Human Services. Office of the National Coordinator for Health Information Technology), author
Richwine, Chelsea J., author
Publication:
[Washington, DC] : Office of the National Coordinator for Health Information Technology, July 2023
Subject(s):
Health Services Needs and Demand
Hospitals
Routinely Collected Health Data
Social Determinants of Health
United States

49. Use of telemedicine among office-based physicians, 2021

Author(s):
Pylypchuk, Yuriy, author
Barker, Wesley, author
Publication:
[Washington, DC] : Office of the National Coordinator for Health Information Technology, March 2023
Subject(s):
Physicians -- statistics & numerical data
Telemedicine -- statistics & numerical data
Telemedicine -- trends
Diffusion of Innovation
Electronic Health Records -- statistics & numerical data
United States

51. Labs with questionably high billing for additional tests alongside COVID-19 tests warrant further scrutiny

Author(s):
Maxwell, Ann, (Deputy Inspector General for Evaluation and Inspections), author
Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, December 2022
Subject(s):
Clinical Laboratory Techniques -- economics
Costs and Cost Analysis
COVID-19 Testing -- economics
Insurance, Health, Reimbursement
Medicare Part B
United States

56. Public health: Leading practices could help guide HHS reform efforts to address risk and improve preparedness : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives

Publication:
Washington, DC : United States Government Accountability Office, June 7, 2023
Subject(s):
Civil Defense -- organization & administration
Government Regulation
Health Care Reform -- legislation & jurisprudence
Legislation, Medical
United States
United States. Department of Health and Human Services

58. Federal research: NIH could take additional actions to manage risks involving foreign subrecipients : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, June 2023
Subject(s):
Government Regulation
Legislation, Medical
Research Support as Topic -- organization & administration
Risk Management
SARS-CoV-2 -- isolation & purification
China
United States
Wuhan da xue
Zhongguo ke xue yuan. Wuhan bing du yan jiu suo
Jun shi yi xue ke xue yuan (China)
National Institutes of Health (U.S.)

62. Medicaid: CMS oversight and guidance could improve Recovery Audit Contractor program : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, June 2023
Subject(s):
Contract Services -- legislation & jurisprudence
Financial Audit -- legislation & jurisprudence
Government Regulation
Legislation, Medical
Medicaid -- legislation & jurisprudence
United States
Medicare Recovery Audit Contractor Program (U.S.)

63. USAID: Management improvements needed to better meet global health mission : report to the Chairman, Committee on Foreign Relations, U.S. Senate

Publication:
Washington, DC : United States Government Accountability Office, June 2023
Subject(s):
Government Regulation
Legislation, Medical
Management Audit
United States Government Agencies -- organization & administration
United States
United States. Agency for International Development. Bureau for Global Health

64. Indian Health Service: Actions needed to improve use of data on adverse events : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, July 2023
Subject(s):
American Indian or Alaska Native -- legislation & jurisprudence
Government Regulation
Legislation, Medical
Outcome and Process Assessment, Health Care
United States
United States. Indian Health Service

66. Defense health care: Additional assessments needed to determine effects of active duty medical personnel reductions : report to congressional committees

Publication:
Washington, DC : United States Government Accountability Office, July 2023
Subject(s):
Government Regulation
Health Workforce -- organization & administration
Legislation, Medical
Military Medicine -- organization & administration
United States
United States. Department of Defense

68. VA health care: Office of the Medical Inspector should strengthen oversight of recommendations and assess performance : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, July 2023
Subject(s):
Government Regulation
Legislation, Medical
Outcome and Process Assessment, Health Care -- legislation & jurisprudence
United States
United States. Veterans Health Administration. Office of the Medical Inspector

69. Unwanted sexual behavior: improved guidance, access to care, and training needed to better address victims’ behavioral health needs : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, August 2023
Subject(s):
Government Regulation
Legislation, Medical
Military Health -- legislation & jurisprudence
Sex Offenses -- prevention & control
Sexual Harassment -- prevention & control
United States
United States. Department of Defense
United States. Department of Veterans Affairs

71. CBO’s 2023 long-term budget projections: presentation at the American Enterprise Institute : methodologies in fiscal, economic, and health spending projections

Author(s):
Dahl, Molly W., author
Publication:
[Washington, D.C.] : Congressional Budget Office, September 22, 2023
Subject(s):
Budgets -- trends
Delivery of Health Care -- economics
Forecasting -- methods
Health Expenditures -- trends
Climate Change -- economics
United States

75. Advancing primary prevention in human services. Opportunities for people with lived experience

Author(s):
Akers, Lauren, author
Tippins, Jennifer Laura, author
Hauan, Susan, author
Lynch-Smith, Miranda, author
Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Human Services Policy, June 2023
Subject(s):
Community Participation
Primary Prevention -- organization & administration
Social Welfare
Social Work
United States

76. Advancing primary prevention in human services. Key considerations for policy designers and funding partners

Author(s):
Akers, Lauren, author
Tippins, Jennifer Laura, author
Hauan, Susan, author
Lynch-Smith, Miranda, author
Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Offices of Human Services Policy, June 2023
Subject(s):
Primary Prevention -- organization & administration
Health Policy
Social Welfare
Social Work
United States

77. Advancing primary prevention in human services. Key considerations for administrators and practitioners

Author(s):
Akers, Lauren, author
Tippins, Jennifer Laura, author
Hauan, Susan, author
Lynch-Smith, Miranda, author
Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Human Services Policy, June 2023
Subject(s):
Primary Prevention -- organization & administration
Social Welfare
Social Work
United States

78. Medicare Part B drugs: trends in spending and utilization, 2008-2021

Author(s):
Nguyen, Nuguyen X., author
Olsen, T. Anders, author
Sheingold, Steven, author
De Lew, Nancy, author
Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, June 9, 2023
Subject(s):
Cost Control
Drug Utilization -- statistics & numerical data
Drug Utilization -- trends
Health Expenditures -- statistics & numerical data
Health Expenditures -- trends
Medicare Part B -- economics
United States
United States.

79. Medicare Part D enrollee out-of-pocket spending: recent trends and projected impacts of the Inflation Reduction Act

Author(s):
Sayed, Bisma A., author
Finegold, Kenneth, 1957- author
Olsen, T. Anders, author
Ashok, Kaavya, author
Shutz, Sarah, author
Sheingold, Steven, author
De Lew, Nancy, author
Sommers, Benjamin D., author
Publication:
Washington, D.C. : Assistant Secretary for Planning and Evaluation, Office of Health Policy, July 7, 2023
Subject(s):
Health Expenditures -- statistics & numerical data
Health Expenditures -- trends
Medicare Part D -- economics
Medicare Part D -- statistics & numerical data
State Government
United States
United States.

80. Updated Medicare FFS telehealth trends by beneficiary characteristics, visit specialty, and state, 2019-2021

Author(s):
Samson, Lok Wong, author
Couture, Sara J., author
Creedon, Tim B., author
Jacobus-Kantor, Laura, author
Sheingold, Steven, author
Publication:
Washington, D.C. : Assistant Secretary for Planning and Evaluation, Office of Health Policy, July 20, 2023
Subject(s):
Medicare -- statistics & numerical data
Medicare -- trends
State Government
Telemedicine -- statistics & numerical data
Telemedicine -- trends
United States

86. CMS has opportunities to strengthen states’ oversight of Medicaid Managed Care Plans’ reporting of medical loss ratios

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2022
Subject(s):
Government Regulation
Managed Care Programs -- organization & administration
Medicaid
State Health Planning and Development Agencies
United States
Centers for Medicare & Medicaid Services (U.S.)

89. During the initial COVID-19 response, HHS personnel who interacted with potentially infected passengers had limited protections

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, October 2022
Subject(s):
Air Travel
COVID-19 -- prevention & control
COVID-19 -- transmission
Government Regulation
Personal Protective Equipment
Travel-Related Illness
United States
United States. Department of Health and Human Services

94. Inaccuracies in Medicare’s race and ethnicity data hinder the ability to assess health disparities

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, June 2022
Subject(s):
Data Accuracy
Ethnicity
Government Regulation
Health Impact Assessment
Healthcare Disparities
Medicare -- organization & administration
Medicare -- statistics & numerical data
Racial Groups
United States