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1. Data inadequacies undermine CMS's oversight of the inconsistency resolution process for the federal marketplace

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, March 2017
Subject(s):
Data Collection
Eligibility Determination
Health Insurance Exchanges
Cost Sharing
Federal Government
Government Regulation
Humans
United States
United States. Department of Health and Human Services.
United States.
Centers for Medicare & Medicaid Services (U.S.)

2. Part D plans generally include drugs commonly used by dual eligibles: 2018

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2018
Subject(s):
Drug Utilization
Dual MEDICAID MEDICARE Eligibility
Formularies as Topic
Medicare Part D
Insurance Benefits
Insurance, Pharmaceutical Services
Humans
United States
United States. Department of Health and Human Services.
United States.

4. The role of ombudsmen in assuring quality for residents of long-term care facilities: straining to make ends meet

Publication:
Washington, D.C. : George Washington University, [2009]
Subject(s):
Long-Term Care
Patient Advocacy
Quality Assurance, Health Care
Residential Facilities
Assisted Living Facilities
Consumer Advocacy
Nursing Homes
Patient Rights
Personnel Staffing and Scheduling
Volunteers
Humans
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

5. Federal mandatory spending for means-tested programs, 2008 to 2028

Publication:
Washington, D.C. : Congressional Budget Office, June 2018
Subject(s):
Federal Government
Health Expenditures -- statistics & numerical data
Health Expenditures -- trends
Medicaid -- economics
Medicare -- economics
Cost Sharing
Food Assistance -- economics
Forecasting
Mandatory Programs -- economics
Medicare Part D -- economics
Humans
United States
United States.

6. Health document submission requirements for tobacco products: (revised)

Publication:
Silver Spring, MD : Center for Tobacco Products, October 2017
Subject(s):
Documentation -- standards
Tobacco Products -- standards
Drug Approval
Health
Terminology as Topic
Tobacco Products -- adverse effects
Tobacco Products -- toxicity
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

7. Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):
Registries -- standards
Tobacco Products -- standards
Manufacturing and Industrial Facilities -- standards
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

10. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):
Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

11. How CBO and JCT analyze major proposals that would affect health insurance coverage

Publication:
[Washington, DC] : Congressional Budget Office, February 2018
Subject(s):
Insurance Coverage -- economics
Insurance Coverage -- legislation & jurisprudence
Insurance, Health -- economics
Insurance, Health -- legislation & jurisprudence
Budgets
Costs and Cost Analysis
Federal Government
Health Benefit Plans, Employee -- economics
Health Benefit Plans, Employee -- legislation & jurisprudence
Income Tax
Medicaid -- economics
Models, Economic
State Government
Taxes
Humans
United States
United States.

12. The effects of terminating payments for cost-sharing reductions

Publication:
Washington, D.C. : Congressional Budget Office, 2017
Subject(s):
Cost Sharing -- economics
Deductibles and Coinsurance -- economics
Health Insurance Exchanges -- economics
Insurance Coverage -- statistics & numerical data
Insurance, Health -- statistics & numerical data
Budgets
Federal Government
Income Tax
Poverty
Humans
United States
United States.

13. Trends in enrollment, offers, eligibility and take-up for employer-sponsored insurance: private sector, by state Medicaid expansion status, 2008-2015

Author(s):
Cooper, Phil, author
Davis, Karen, author
Miller, G. Edward, author
Publication:
Rockville, MD : Agency for Healthcare Research and Quality, February 2017
Subject(s):
Eligibility Determination
Health Benefit Plans, Employee -- statistics & numerical data
Health Benefit Plans, Employee -- trends
Health Benefit Plans, Employee -- utilization
Medicaid
Forecasting
Health Care Surveys
Private Sector
State Government
Humans
United States
United States.
Medical Expenditure Panel Survey (U.S.)

14. Federal subsidies for health insurance coverage for people under age 65: 2017 to 2027

Publication:
Washington, D.C. : Congressional Budget Office, September 2017
Subject(s):
Cost Sharing -- statistics & numerical data
Cost Sharing -- trends
Insurance Coverage -- statistics & numerical data
Insurance Coverage -- trends
Insurance, Health -- statistics & numerical data
Insurance, Health -- trends
Adult
Child
Child Health Services
Federal Government
Forecasting
Health Benefit Plans, Employee
Infant
Medicaid
Medically Uninsured -- statistics & numerical data
Medicare
Middle Aged
State Government
Humans
United States
United States.
State Children's Health Insurance Program (U.S.)

15. Preliminary analysis of legislation that would replace subsidies for health care with block grants

Publication:
Washington, D.C. : Congressional Budget Office, September 2017
Subject(s):
Budgets -- legislation & jurisprudence
Budgets -- statistics & numerical data
Budgets -- trends
Financing, Government -- legislation & jurisprudence
Insurance Coverage -- economics
Insurance Coverage -- legislation & jurisprudence
Insurance Coverage -- trends
Insurance, Health -- economics
Insurance, Health -- legislation & jurisprudence
Insurance, Health -- trends
Federal Government
Forecasting
Health Insurance Exchanges -- economics
Health Insurance Exchanges -- legislation & jurisprudence
Health Insurance Exchanges -- trends
Insurance, Major Medical -- economics
Insurance, Major Medical -- trends
Medicaid -- economics
Medicaid -- legislation & jurisprudence
Medically Uninsured -- legislation & jurisprudence
Medically Uninsured -- statistics & numerical data
State Government
Taxes
Humans
United States
United States.

20. The Ryan White HIV/AIDS Program: the basics

Publication:
Washington, D.C. : George Washington University, [2010]
Subject(s):
Acquired Immunodeficiency Syndrome -- economics
HIV Infections -- economics
Medical Assistance -- legislation & jurisprudence
Acquired Immunodeficiency Syndrome -- therapy
Antiretroviral Therapy, Highly Active -- economics
Government Programs
HIV Infections -- therapy
Medical Assistance -- economics
Medically Uninsured
Humans
United States
United States.

21. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
Subject(s):
Device Approval -- standards
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

24. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2017
Subject(s):
Emergency Medical Services -- legislation & jurisprudence
Emergency Responders -- legislation & jurisprudence
Pharmaceutical Preparations -- supply & distribution
Drug Therapy
Legislation, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

25. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2017
Subject(s):
Automatic Data Processing -- standards
Investigational New Drug Application
Drug Approval -- legislation & jurisprudence
Drug Approval -- organization & administration
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

26. Medicaid expansion: behavioral health treatment use in selected states in 2014 : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, June 2017
Subject(s):
Medicaid
Mental Disorders -- drug therapy
Mental Disorders -- therapy
Mental Health Services -- utilization
Analgesics, Opioid -- therapeutic use
Forecasting
Mental Health Services -- trends
Opioid-Related Disorders
Humans
Iowa
New York
Washington
West Virginia
United States
United States.

27. Improper payments: improvements needed in CMS and IRS controls over health insurance premium tax credit : report to Congressional committees

Publication:
Washington, D.C. : U.S. Government Accountability Office, July 2017
Subject(s):
Cost Sharing -- economics
Government Regulation
Health Insurance Exchanges -- economics
Income Tax
Eligibility Determination
Insurance, Health -- economics
Humans
United States
United States. Internal Revenue Service.
United States.
Centers for Medicare & Medicaid Services (U.S.)

28. Health insurance marketplaces: CMS needs to improve its oversight of state IT systems' sustainability and performance : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, August 2017
Subject(s):
Government Regulation
Health Insurance Exchanges -- organization & administration
Medical Informatics -- organization & administration
Federal Government
Financing, Government
State Government
Humans
Hawaii
Minnesota
New York
Oregon
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

29. Affordable Care Act: IRS should mitigate limitations of data to be used for the age and gender adjustment for the tax on high-cost health plans : report to Congressional committees

Publication:
Washington, D.C. : U.S. Government Accountability Office, September 2017
Subject(s):
Age Factors
Health Benefit Plans, Employee -- economics
Sex Factors
Taxes -- legislation & jurisprudence
Blue Cross Blue Shield Insurance Plans -- economics
Government Employees
Health Care Costs
Humans
United States
United States. Internal Revenue Service.
United States.

30. State health- insurance marketplaces: three states used varied data sources for eligibility and had few indications of potentially improper enrollments : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, September 2017
Subject(s):
Cost Sharing -- economics
Eligibility Determination
Health Insurance Exchanges
Insurance, Health -- economics
Fraud
Income Tax
Humans
Idaho
Maryland
Rhode Island
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

31. Part D plans generally include drugs commonly used by dual eligibles: 2017

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2017
Subject(s):
Dual MEDICAID MEDICARE Eligibility
Formularies as Topic
Insurance Coverage
Medicare Part D -- statistics & numerical data
Drug Utilization
Medicare Part D -- economics
Humans
United States
United States. Department of Health and Human Services.
United States.

32. Health insurance exchanges: changes in benchmark plans and premiums and effects of automatic re-enrollment on consumers' costs : report to Congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, November 2017
Subject(s):
Benchmarking
Consumer Behavior
Costs and Cost Analysis
Health Insurance Exchanges -- economics
Insurance, Health -- economics
Eligibility Determination
Financing, Personal
Humans
United States
United States.

33. Access to preventive services without cost-sharing: evidence from the Affordable Care Act

Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, January 11, 2022
Subject(s):
Cost Sharing
Health Services Accessibility
Preventive Health Services -- economics
Facilities and Services Utilization -- statistics & numerical data
United States
United States.

34. Federal economic stimulus projected to cut poverty in 2021, though poverty may rise as benefits expire

Author(s):
Macartney, Suzanne E., author
Ghertner, Robin, author
Wheaton, Laura, author
Giannarelli, Linda, author
Publication:
Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, February 2022
Subject(s):
COVID-19 -- economics
Poverty -- ethnology
Poverty -- legislation & jurisprudence
Poverty -- statistics & numerical data
Public Assistance -- statistics & numerical data
Income Tax
United States
United States.

35. Referencing the definition of “device” in the Federal Food, Drug, and Cosmetic Act in guidance, regulatory documents, communications, and other public documents: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 14, 2022
Subject(s):
Government Regulation
Medical Device Legislation
Terminology as Topic
United States
United States. Food and Drug Administration
United States.

36. Insulin affordability and the Inflation Reduction Act: Medicare beneficiary savings by state and demographics

Author(s):
Sayed, Bisma A., author
Finegold, Kenneth, 1957- author
Olsen, T. Anders, author
De Lew, Nancy, author
Sheingold, Steven, author
Ashok, Kaavya, author
Sommers, Benjamin D., author
Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, January 24, 2023
Subject(s):
Costs and Cost Analysis
Drug Costs -- legislation & jurisprudence
Drug Costs -- statistics & numerical data
Insulin -- economics
Medicare -- economics
State Government
Ethnicity
Racial Groups
United States
United States.

37. Health coverage under the Affordable Care Act. Current enrollment trends and state estimates

Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, March 23, 2023
Subject(s):
Insurance Coverage -- statistics & numerical data
Insurance Coverage -- trends
Medicaid -- statistics & numerical data
Medicaid -- trends
Medically Uninsured -- statistics & numerical data
State Government
United States
United States.

38. Electronic health information exchange: use has increased, but is lower for small and rural providers : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, April 2023
Subject(s):
Government Regulation
Health Information Exchange -- economics
Health Information Exchange -- legislation & jurisprudence
Legislation, Medical
Rural Health Services -- economics
United States
United States.

39. The cost of not expanding Medicaid

Author(s):
Holahan, John, author
Buettgens, Matthew, author
Dorn, Stan, author
Publication:
Menlo Park, CA : Henry J. Kaiser Family Foundation, July 2013
Subject(s):
Health Care Reform -- economics
Health Care Reform -- legislation & jurisprudence
Health Care Reform -- statistics & numerical data
Insurance Coverage -- economics
Insurance Coverage -- legislation & jurisprudence
Insurance Coverage -- statistics & numerical data
Insurance, Health -- economics
Insurance, Health -- legislation & jurisprudence
Insurance, Health -- statistics & numerical data
Medicaid -- economics
Medicaid -- legislation & jurisprudence
Medicaid -- statistics & numerical data
Medically Uninsured -- legislation & jurisprudence
Medically Uninsured -- statistics & numerical data
United States
United States.

40. Interoperability among office-based physicians in 2019

Author(s):
Pylypchuk, Yuriy, author
Everson, Jordan, author
Charles, Dustin, author
Patel, Vaishali, author
Publication:
Washington, DC : Office of the National Coordinator for Health Information Technology, July 2022
Subject(s):
Electronic Health Records -- trends
Health Information Interoperability -- trends
Physicians
Diffusion of Innovation
United States
United States.

43. Health coverage changes under the Affordable Care Act: end of 2021 update

Author(s):
Lee, Aiden, author
Chu, Rose C., author
Peters, Christie, author
Sommers, Benjamin D., author
Publication:
Washington, D.C. : Assistant Secretary for Planning and Evaluation, Office of Health Policy April 29, 2022
Subject(s):
Insurance Coverage -- statistics & numerical data
Insurance Coverage -- trends
Medically Uninsured -- statistics & numerical data
Medicaid -- statistics & numerical data
Medicaid -- trends
United States
United States.

44. HealthCare.gov marketplace enrollment during the 2021 special enrollment period by race and ethnicity

Author(s):
Branham, D. Keith, author
Finegold, Kenneth, 1957- author
Peters, Christie, author
Sommers, Benjamin D., author
Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, March 24, 2022
Subject(s):
Ethnicity -- statistics & numerical data
Health Insurance Exchanges -- statistics & numerical data
Insurance Coverage -- statistics & numerical data
Racial Groups -- statistics & numerical data
United States
United States.

45. Health coverage for women under the Affordable Care Act

Author(s):
Sugar, Sarah, author
Ruhter, Joel, author
Gordon, Sarah, author
Whitman, Amelia, author
Peters, Christie, author
De Lew, Nancy, author
Sommers, Benjamin D., author
Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, March 21, 2022
Subject(s):
Insurance Coverage -- statistics & numerical data
Insurance Coverage -- trends
Medically Uninsured -- statistics & numerical data
Women
United States
United States.

47. Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Subject(s):
Legislation, Drug
Legislation, Food
Marketing -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

49. Medicaid eligibility: accurate beneficiary enrollment requires improvements in oversight, data, and collaboration : testimony before the Subcommittee on Health Care, Committee on Finance, U.S. Senate

Publication:
Washington, DC : United States Government Accountability Office, October 30, 2019
Subject(s):
Eligibility Determination
Government Regulation
Medicaid -- economics
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

50. Indian Health Service: facilities reported expanding services following increases in health insurance coverage and collections : report to Congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, September 2019
Subject(s):
Alaskan Natives
American Natives
Insurance Coverage -- legislation & jurisprudence
Medicaid -- legislation & jurisprudence
Insurance Coverage -- statistics & numerical data
United States
United States. Indian Health Service
United States.

51. Comparative effectiveness research: Patient-Centered Outcomes Research Institute and HHS continue activities and plan new efforts : report to Congressional committees

Publication:
Washington, DC : United States Government Accountability Office, November 2020
Subject(s):
Government Regulation
Patient-Centered Care -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States.

52. Mental health and substance use: state and federal oversight of compliance with parity requirements varies : report to Congressional committees

Publication:
Washington, DC : United States Government Accountability Office, December 2019
Subject(s):
Drug Users -- legislation & jurisprudence
Government Regulation
Healthcare Disparities -- legislation & jurisprudence
Mental Health Services -- legislation & jurisprudence
Substance-Related Disorders
United States
United States. Department of Health and Human Services
United States.

54. Health coverage under the Affordable Care Act: enrollment trends and state estimates

Publication:
Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, June 5, 2021
Subject(s):
Insurance Coverage -- statistics & numerical data
Insurance Coverage -- trends
State Government
United States
United States. Department of Health and Human Services.
United States.

56. Medicare: Information on the transition to alternative payment models by providers in rural, health professional shortage, or underserved areas : report to congressional committees

Publication:
Washington, DC : United States Government Accountability Office, November 2021
Subject(s):
Government Regulation
Medically Underserved Area
Quality Assurance, Health Care -- organization & administration
Rural Health -- legislation & jurisprudence
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

57. COVID-19: Selected states modified meal provision and other Older Americans Act services to prioritize safety : report to congressional addressees

Publication:
Washington, DC : United States Government Accountability Office, December 2021
Subject(s):
Food Services -- economics
Health Services for the Aged -- economics
Home Care Services -- organization & administration
Government Regulation
COVID-19
United States
United States.

59. States reported multiple challenges with using telehealth to provide behavioral health services to Medicaid enrollees

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2021
Subject(s):
Computer User Training -- economics
Government Regulation
Internet Access -- economics
Medicaid -- economics
Mental Health Services -- organization & administration
Telemedicine -- organization & administration
United States
United States. Department of Health and Human Services
United States.

60. Analysis of 2017 premium changes and insurer participation in the Affordable Care Act's health insurance marketplaces

Author(s):
Cox, Cynthia, author
Claxton, Gary, author
Levitt, Larry, author
Long, Michelle, author
Gonzales, Selena, author
Sroczynski, Nolan, author
Publication:
Menlo Park, CA : Henry J. Kaiser Family Foundation, July 2016
Subject(s):
Health Insurance Exchanges -- economics
Health Insurance Exchanges -- statistics & numerical data
Insurance, Health -- economics
Insurance, Health -- statistics & numerical data
United States
United States.

62. Effects of the Patient Protection and Affordable Care Act on coverage and access to care in metropolitan vs. non-metropolitan areas through 2016

Author(s):
Wehby, George L., author
Lyu, Wei, author
Shane, Dan M., author
Publication:
Iowa City, IA : Rural Policy Research Institute, August 2019
Subject(s):
Insurance Coverage -- statistics & numerical data
Insurance, Health -- statistics & numerical data
Rural Population
Urban Population
Medicaid -- statistics & numerical data
United States
United States.

66. Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Electronic Nicotine Delivery Systems -- standards
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Product Labeling -- standards
Vaping -- legislation & jurisprudence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

67. REMS: FDA's application of statutory factors in determining when a REMS is necessary

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2019
Subject(s):
Drug Evaluation -- legislation & jurisprudence
Risk Evaluation and Mitigation -- legislation & jurisprudence
Cost of Illness
Drug-Related Side Effects and Adverse Reactions
Health Services Accessibility
Prescription Drugs -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

68. Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2019
Subject(s):
Anthrax -- drug therapy
Civil Defense
Doxycycline -- supply & distribution
Doxycycline -- therapeutic use
Post-Exposure Prophylaxis
Strategic Stockpile
Biological Availability
Drug Stability
Drug Storage
Legislation, Drug
Biological Availability
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

69. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, December 16, 2019
Subject(s):
Device Approval -- standards
Equipment and Supplies -- standards
Manufactured Materials -- standards
Device Approval -- legislation & jurisprudence
Time Factors
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

71. FDA deems certain tobacco products subject to FDA authority, sales and distribution restrictions, and health warning requirements for packages and advertisements: (revised)

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Commerce -- legislation & jurisprudence
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Tobacco Products -- supply & distribution
Advertising -- legislation & jurisprudence
Tobacco Products -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

72. Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Guideline Adherence
Tobacco Products -- adverse effects
Tobacco Products -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

73. Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Product Labeling -- legislation & jurisprudence
Vaping -- legislation & jurisprudence
Commerce -- legislation & jurisprudence
Guideline Adherence
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

74. Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
Subject(s):
Drug Compounding -- standards
5-Hydroxytryptophan -- therapeutic use
Phenylketonurias -- drug therapy
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

75. Citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Drug Approval -- legislation & jurisprudence
Investigational New Drug Application -- legislation & jurisprudence
Public Health -- legislation & jurisprudence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

76. Wholesale distributor verification requirement for saleable returned drug product: compliance policy

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Commerce -- legislation & jurisprudence
Legislation, Drug
Pharmaceutical Preparations -- standards
Drug Labeling
Drug Packaging
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

77. Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 27, 2019
Subject(s):
Equipment and Supplies -- standards
Software -- legislation & jurisprudence
Electronic Health Records
Healthy Lifestyle
Hospital Information Systems
Mobile Applications -- legislation & jurisprudence
Software -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
United States.

78. Prescription Drug User Fee Act waivers, reductions, and refunds for drug and biological products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2019
Subject(s):
Drug Approval -- economics
Drug Approval -- legislation & jurisprudence
Investigational New Drug Application -- legislation & jurisprudence
Diffusion of Innovation
Economics, Pharmaceutical
Orphan Drug Production -- economics
Public Health
Small Business
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

79. Process to request a review of FDA's decision not to issue certain export certificates for devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 14, 2019
Subject(s):
Commerce -- legislation & jurisprudence
Equipment and Supplies -- standards
Device Approval -- legislation & jurisprudence
Equipment Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

83. Part D plans generally include drugs commonly used by dual eligibles: 2019

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2019
Subject(s):
Dual MEDICAID MEDICARE Eligibility
Formularies as Topic
Insurance Coverage
Medicare Part D -- economics
Insurance, Pharmaceutical Services -- economics
Medicaid -- economics
Medicare -- economics
Humans
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

84. 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.

85. 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.

87. 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.

88. 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.

93. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.

94. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Counterfeit Drugs
Drug Industry
Drug and Narcotic Control
Fraud
Government Regulation
Substandard Drugs
United States
United States.

96. CARES Act: experts identified safeguards to help selected HHS agencies protect against potential political interference : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, September 2023
Subject(s):
Government Regulation
Legislation, Medical
Politics
Professional Misconduct
United States
United States.
United States. Department of Health and Human Services

97. Medicare cognitive assessments: utilization tripled between 2018 and 2022, but challenges remain : report to congressional committees

Publication:
Washington, DC : United States Government Accountability Office, December 2023
Subject(s):
Alzheimer Disease
Government Regulation
Healthcare Disparities
Medicare
Mental Status and Dementia Tests -- statistics & numerical data
Neurocognitive Disorders
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

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Current results range from 2003 to 2023