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1. The "deemed to be a license" provision of the BPCI Act: questions and answers

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, March 2020

Subject(s):

Biological Products
Drug Approval
Licensure
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. The 2018 long-term budget outlook

Publication:

Washington, D.C. : Congressional Budget Office, June 2018

Subject(s):

Budgets -- trends
Federal Government
Forecasting
Medicare -- economics
Medicare -- trends
Social Security -- economics
Social Security -- trends
Humans
United States

3. The 2019 long-term budget outlook

Publication:

[Washington, DC] : Congressional Budget Office, June 2019

Subject(s):

Budgets -- trends
Gross Domestic Product -- trends
Demography
Federal Government
Forecasting
Medicare -- economics
Medicare -- trends
Social Security -- economics
Social Security -- trends
Humans
United States

4. 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.

5. 340B Drug Discount Program: oversight of the Intersection with the Medicaid Drug Rebate Program needs improvement : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, January 2020

Subject(s):

Drug Costs -- legislation & jurisprudence
Government Regulation
Medicaid -- economics
United States
United States. Department of Health and Human Services

6. 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, March 12, 2020

Subject(s):

Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. ACF cannot ensure that all child victims of abuse and neglect have court representation

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, March 2021

Subject(s):

Child Abuse -- legislation & jurisprudence
Child Protective Services -- standards
Government Regulation
Legal Services -- organization & administration
United States
United States. Department of Health and Human Services

8. ACF should improve oversight of head start to better protect children’s safety

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2022

Subject(s):

Child Health
Government Regulation
Early Intervention, Educational
United States
United States. Administration for Children and Families

9. ACOs' strategies for transitioning to value-based care: lessons from the Medicare shared savings program

Publication:

[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, July 2019

Subject(s):

Accountable Care Organizations -- economics
Cost Savings
Medicare -- economics
Quality of Health Care
Value-Based Purchasing
Cost Sharing
Electronic Health Records
Health Information Exchange
Home Care Services
Hospitalization
Mental Health Services
Multiple Chronic Conditions
Patient Transfer
Reimbursement Mechanisms
Skilled Nursing Facilities
Social Determinants of Health
Humans
United States

10. ANDA submissions--amendments to abbreviated new drug applications under GDUFA

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, July 2018

Subject(s):

Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

11. ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2020

Subject(s):

Drug Approval
Drug Industry
Drugs, Generic
Therapeutic Equivalency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2021

Subject(s):

Chemistry Techniques, Synthetic
DNA, Ribosomal
Drug Approval
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

13. Abuse and neglect: CMS should strengthen reporting requirements to better protect individuals receiving hospice care : report to the Honorable Charles E. Grassley, United States Senate

Publication:

Washington, DC : United States Government Accountability Office, December 2022

Subject(s):

Elder Abuse -- legislation & jurisprudence
Government Regulation
Hospice Care -- legislation & jurisprudence
Legislation, Medical
Mandatory Reporting
Medicaid -- organization & administration
Medicare -- organization & administration
United States
Centers for Medicare & Medicaid Services (U.S.)

14. Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, December 16, 2019

Subject(s):

Device Approval -- standards
Checklist
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. Access and use of electronic health information by individuals with cancer: 2017-2018

Author(s):

Johnson, Christian, MPH, author
Krakow, Melinda, author
Patel, Vaishali, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, January 2020

Subject(s):

Electronic Health Records -- statistics & numerical data
Facilities and Services Utilization -- statistics & numerical data
Health Services Accessibility -- statistics & numerical data
Neoplasms
United States
United States. Department of Health and Human Services.

16. Access to Medicare Part D plans: a comparison of metropolitan and nonmetropolitan areas

Author(s):

Nataliansyah, Mochamad, author
Salako, Abiodun, author
Ullrich, Fred, author
Mueller, Keith, author

Publication:

Iowa City, IA : Rural Policy Research Institute, May 2020

Subject(s):

Medicare Part D -- statistics & numerical data
Rural Population
Urban Population
United States

17. 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.

18. The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020

Subject(s):

Accreditation
Equipment and Supplies
Materials Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Achieving behavioral health care integration in rural America

Publication:

Washington, DC : Bipartisan Policy Center, May 2023

Subject(s):

Behavioral Medicine
Community Mental Health Services
Health Promotion -- legislation & jurisprudence
Health Services Accessibility
Rural Health Services
Social Determinants of Health
United States

20. Acne vulgaris: establishing effectiveness of drugs intended for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2018

Subject(s):

Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

21. Action level for inorganic arsenic in apple juice: guidance for industry

Publication:

College Park, MD : Center for Food Safety and Applied Nutrition, June 2023

Subject(s):

Arsenic
Food Safety
Food Supply
Government Regulation
United States

22. Acute myeloid leukemia: developing drugs and biological products for treatment : guidance for industry

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, October 2022

Subject(s):

Biological Products
Drug Development -- legislation & jurisprudence
Government Regulation
Leukemia, Myeloid, Acute -- drug therapy
United States
United States. Food and Drug Administration

23. Adaptive designs for clinical trials of drugs and biologics

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, November 2019

Subject(s):

Adaptive Clinical Trials as Topic -- standards
Investigational New Drug Application
Adaptive Clinical Trials as Topic -- ethics
Biological Products
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

24. Addressing social determinants of health: examples of successful evidence-based strategies and current federal efforts

Author(s):

Whitman, Amelia, author
De Lew, Nancy, author
Chappel, Andre, author
Aysola, Victoria, author
Zuckerman, Rachael, author

Publication:

[Washington, D.C.] : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, April 1, 2022

Subject(s):

Delivery of Health Care, Integrated
Evidence-Based Practice
Federal Government
Social Determinants of Health
United States

25. Addressing the direct care workforce shortage: a bipartisan call to action

Publication:

Washington, DC : Bipartisan Policy Center, December 2023

Subject(s):

Emigrants and Immigrants
Government Regulation
Health Policy
Health Workforce
Home Care Services
Home Health Aides
Home Health Nursing
Medicare
United States

26. Adjusting for covariates in randomized clinical trials for drugs and biological products: guidance for industry

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2023

Subject(s):

Biological Products
Drug Industry
Government Regulation
Pharmaceutical Preparations
Randomized Controlled Trials as Topic
United States

27. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017

Subject(s):

Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

28. Adolescent and young adult substance use: federal grants for prevention, treatment, and recovery services and for research : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, September 2018

Subject(s):

Financing, Government
Substance-Related Disorders -- prevention & control
Adolescent
Young Adult
United States
United States. Department of Education.
United States. Department of Health and Human Services.
United States. Department of Justice.

29. Advance care planning among Medicare fee-for-service beneficiaries and practitioners: final report

Author(s):

He, Fang, author
Gasdaska, Angela, author
Friedman, Hannah, author
Wedehas, Brendan, author
Kirk, Alexis, author
Broyles, Ila, author
Karon, Sarita L., author

Publication:

[Washington, D.C.] : United States Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, September 2020

Subject(s):

Advance Care Planning
Medicare
Fee-for-Service Plans
United States

30. Advanced prostate cancer: developing gonadotropin-releasing hormone analogues

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2022

Subject(s):

Drug Development -- legislation & jurisprudence
Gonadotropin-Releasing Hormone
Prostatic Neoplasms -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

31. Advancement of emerging technology applications for pharmaceutical innovation and modernization

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Biomedical Technology -- standards
Drug Industry -- standards
Inventions
Quality Assurance, Health Care
Quality Improvement
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

32. Advancing comprehensive primary care in Medicaid

Publication:

Washington, DC : Bipartisan Policy Center, July 2020

Subject(s):

Medicaid -- legislation & jurisprudence
Medicaid -- organization & administration
Medicaid -- standards
Primary Health Care
Healthcare Disparities
Insurance, Health
United States

33. 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

34. 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

35. 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

36. Advancing primary prevention in human services: convening findings

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, March 2023

Subject(s):

Community Support
Ill-Housed Persons
Poverty
Primary Prevention
Social Support
Social Work -- organization & administration
United States

37. Adverse events in hospitals. A quarter of Medicare patients experienced harm in October 2018

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, May 2022

Subject(s):

Government Regulation
Hospitals
Medicare
Patient Harm -- prevention & control
Patient Harm -- statistics & numerical data
Patient Safety
United States

38. Adverse events in long-term-care hospitals: national incidence among Medicare beneficiaries

Publication:

[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, November 2018

Subject(s):

Hospitals -- statistics & numerical data
Incidence
Long-Term Care -- statistics & numerical data
Medical Errors -- statistics & numerical data
Medicare
Hospital Mortality
Medical Errors -- prevention & control
Patient Safety
Quality Indicators, Health Care
Quality of Health Care
Subacute Care
Humans
United States
United States. Agency for Healthcare Research and Quality.
Centers for Medicare & Medicaid Services (U.S.)

39. Adverse events toolkit. Clinical guidance for identifying harm

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, July 2023

Subject(s):

Evaluation Studies as Topic
Government Regulation
Medical Errors
Patient Harm
Risk Management
United States

40. Adverse events toolkit. Medical record review methodology

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, July 2023

Subject(s):

Evaluation Studies as Topic
Government Regulation
Medical Errors
Medical Records
Patient Harm
Risk Management
United States

41. 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.

42. The aging services network: accomplishments and challenges in serving a growing elderly population

Publication:

Washington, D.C. : George Washington University, [2008]

Subject(s):

Community Health Services -- legislation & jurisprudence
Health Services for the Aged -- legislation & jurisprudence
Health Services for the Aged -- trends
Health Services Needs and Demand -- trends
Aged
Aging
Continuity of Patient Care
Forecasting
Health Services for the Aged -- economics
Long-Term Care -- economics
Long-Term Care -- legislation & jurisprudence
Social Welfare -- legislation & jurisprudence
Vulnerable Populations -- legislation & jurisprudence
Humans
United States

43. Air ambulance: data collection and transparency needed to enhance DOT oversight : report to the Committee on Transportation and Infrastructure, House of Representatives

Publication:

Washington, D.C. : U.S. Government Accountability Office, July 2017

Subject(s):

Air Ambulances -- economics
Fees and Charges
Insurance Coverage -- economics
Cost Sharing
Data Collection
Disclosure
Government Regulation
Humans
United States
United States. Department of Transportation.
Centers for Medicare & Medicaid Services (U.S.)

44. Air travel and communicable diseases: Federal leadership needed to advance research : report to congressional committees

Publication:

Washington, DC : United States Government Accountability Office, July 2022

Subject(s):

Air Travel
Disease Transmission, Infectious -- legislation & jurisprudence
Government Regulation
Legislation, Medical
Travel-Related Illness -- prevention & control
United States

45. Air travel and communicable diseases: status of research efforts and action still needed to develop federal preparedness plan : testimony before the Subcommittee on Space and Aeronautics, Committee on Science, Space, and Technology, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, June 23, 2020

Subject(s):

Air Travel
Communicable Diseases -- transmission
Disaster Planning -- legislation & jurisprudence
Government Regulation
Pandemics -- legislation & jurisprudence
Travel-Related Illness
COVID-19 -- transmission
United States

46. Alaska State Medicaid Fraud Control Unit: 2016 onsite review

Publication:

[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017

Subject(s):

Fraud -- prevention & control
Medicaid
Federal Government
State Government
Humans
Alaska
United States
United States. Department of Health and Human Services.

47. All the material facts in the history of epidemic cholera: being a report of the College of Physicians of Philadelphia, to the Board of Health; and a full account of the causes, post mortem appearances, and treatment of the disease

Author(s):

Bell, John, 1796-1872

Publication:

Philadelphia, Desilver, 1832

Subject(s):

Cholera

48. Allergic rhinitis: developing drug products for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2018

Subject(s):

Clinical Trials as Topic
Drug Evaluation
Rhinitis, Allergic -- drug therapy
Adrenal Cortex Hormones -- therapeutic use
Adult
Child
Drug Combinations
Research Design
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

49. Alternative payment models and the slowdown in federal health care spending: testimony before the Committee on the Budget, United States Senate

Author(s):

Cohen, Michael, (Of Congressional Budget Office), author
White, Chapin, author

Publication:

[Washington, D.C.] : Congressional Budget Office, October 18, 2023

Subject(s):

Accountable Care Organizations
Federal Government
Health Expenditures -- trends
Reimbursement Mechanisms
United States

50. Alternative procedures for blood and blood components during the COVID-19 public health emergency

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, April 2020

Subject(s):

Blood Donors
Blood Transfusion
Plasma
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

51. 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

52. Amyotrophic lateral sclerosis: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2019

Subject(s):

Amyotrophic Lateral Sclerosis -- drug therapy
Clinical Trials as Topic -- standards
Drug Development -- standards
Pharmacokinetics
Research Design -- standards
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

53. 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.

54. An analysis of private-sector prices for hospital admissions

Author(s):

Maeda, Jared Lane, author
Nelson, Lyle, author

Publication:

[Washington, D.C.] : Congressional Budget Office, April 2017

Subject(s):

Hospital Costs -- statistics & numerical data
Insurance, Health, Reimbursement
Medicare -- economics
Medicare Part C -- economics
Private Sector
Diagnosis-Related Groups
Fee-for-Service Plans -- economics
Health Expenditures -- statistics & numerical data
Reimbursement Mechanisms
Humans
United States

55. An analysis of private-sector prices for physicians' services

Author(s):

Pelech, Daria, author

Publication:

Washington, D.C. : Congressional Budget Office, January 2018

Subject(s):

Fee-for-Service Plans -- economics
Fees and Charges -- statistics & numerical data
Medicare -- economics
Physicians
Medicare Part C -- economics
Private Sector
Humans
United States

56. Anesthesia services: differences between private and Medicare payments likely due to providers' strong negotiating position : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, October 2020

Subject(s):

Anesthesia -- economics
Medicare -- economics
United States
Centers for Medicare & Medicaid Services (U.S.)

57. Animal use in research: NIH should strengthen oversight of projects it funds at foreign facilities : report to congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, March 2023

Subject(s):

Animal Experimentation -- legislation & jurisprudence
Animal Experimentation -- standards
Government Regulation
International Cooperation -- legislation & jurisprudence
Legislation, Medical
Research -- economics
United States

58. Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2023

Subject(s):

Forms as Topic
Government Regulation
Product Surveillance, Postmarketing
United States
United States.
United States.

59. Answering the call: 988 : a new vision for crisis response

Publication:

Washington, D.C. : Bipartisan Policy Center, June 2022

Subject(s):

Crisis Intervention -- organization & administration
Hotlines
United States

60. Answers to questions for the record following a hearing conducted by the House Committee on the Budget: key design components and considerations for establishing a single-payer health care system

Publication:

[Washington, DC] : Congressional Budget Office, December 20, 2019

Subject(s):

Single-Payer System -- organization & administration
Budgets
United States

61. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2018

Subject(s):

Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

62. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, August 2017

Subject(s):

Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Approval
Drug Resistance, Bacterial
Investigational New Drug Application
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

63. Antibiotic resistance: Federal agencies have taken steps to combat the threat, but additional actions needed : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, April 28, 2023

Subject(s):

Drug Resistance, Microbial
Government Regulation
Legislation, Medical
United States
United States. Department of Health and Human Services

64. Antibiotic resistance: additional federal actions needed to better determine magnitude and reduce impact

Publication:

Washington, DC : United States Government Accountability Office, March 2020

Subject(s):

Bacterial Infections -- therapy
Drug Resistance, Bacterial
Diagnostic Techniques and Procedures
Epidemiological Monitoring
Government Regulation
United States
Centers for Disease Control and Prevention (U.S.)

65. Antibiotic resistance: more information needed to oversee use of medically important drugs in food animals : report to Congressional requesters

Publication:

Washington, D.C. : U.S. Government Accountability Office, March 2017

Subject(s):

Anti-Bacterial Agents -- adverse effects
Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Resistance, Bacterial
Drug Resistance, Microbial
Food -- adverse effects
Food Inspection
Food Safety
Foodborne Diseases -- microbiology
Veterinary Drugs -- adverse effects
Veterinary Drugs -- therapeutic use
Bacterial Infections -- epidemiology
Cattle
Disease Outbreaks -- prevention & control
Foodborne Diseases -- epidemiology
Poultry
Swine
World health
Humans
Canada
Denmark
Netherlands
United States
United States. Department of Agriculture.
United States. Department of Health and Human Services.

66. Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters

Publication:

Washington, D.C. : U.S. Government Accountability Office, January 2017

Subject(s):

Anti-Bacterial Agents -- therapeutic use
Drug Approval
Drug Industry
Drugs, Investigational
Investigational New Drug Application
Drug Resistance, Bacterial
Guidelines as Topic
Humans
United States
United States. Food and Drug Administration.

67. Antimicrobial susceptibility test (AST) system devices: updating breakpoints in device labeling : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2023

Subject(s):

Government Regulation
Medical Device Legislation
Microbial Sensitivity Tests -- standards
Product Labeling
United States

68. Antipsychotic medication prescribing in long-term care facilities increased in the early months of the COVID-19 pandemic

Author(s):

Oliveira, Iara, author
Bianco, Martin, author
Ali, Mir M., (Health economist) author

Publication:

Washington, D.C. : Assistant Secretary for Planning and Evaluation, March 8, 2022

Subject(s):

COVID-19
Antipsychotic Agents -- therapeutic use
Inappropriate Prescribing -- trends
Long-Term Care
Nursing Homes
United States

69. Antiviral drugs: Economic incentives and strategies for pandemic preparedness : report to congressional committees

Publication:

Washington, DC : United States Government Accountability Office, September 2023

Subject(s):

Antiviral Agents -- economics
Antiviral Agents -- supply & distribution
Government Regulation
Legislation, Medical
Pandemic Preparedness
Technology Assessment, Biomedical
United States

70. Appeal options available to mammography facilities concerning adverse accreditation decisions, suspension/revocation of certificates, or patient and physician notification orders: guidance for mammography facilities and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, March 2, 2022

Subject(s):

Accreditation
Facility Regulation and Control
Mammography
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

71. Appendix I (B) to the ICH E2B(R3) ICSRs implementation guide: backwards and forwards compatibility

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, April 2022

Subject(s):

Clinical Coding
Databases, Pharmaceutical
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

72. Application of basic physiologic data in the design of AAF oxygen equipment

Author(s):

Carlson, Loren D. (Loren Daniel), 1915-1972, author
Wulff, V. J., author

Publication:

Dayton, Ohio : Army Air Forces, Headquarters Air Technical Service Command, 9 November 1945

Subject(s):

Ventilators, Mechanical
Equipment Design
Oxygen Consumption -- physiology
Military Personnel
Aircraft
World War II
United States

73. Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 2023

Subject(s):

Bioengineering
Device Approval
Drug Development
Drug Industry
Ergonomics
Government Regulation
United States

74. Approaches to changing military health care

Publication:

Washington, D.C. : Congressional Budget Office, October 2017

Subject(s):

Health Care Reform -- organization & administration
Military Medicine -- organization & administration
Budgets
Contract Services
Cost Control
Cost Sharing
Military Medicine -- economics
Military Personnel
Humans
United States
United States. Department of Defense.

75. 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.

76. Arkansas Medicaid Fraud Control Unit: 2019 onsite inspection

Publication:

[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2020

Subject(s):

Forms and Records Control -- standards
Fraud -- legislation & jurisprudence
Government Regulation
Medicaid -- legislation & jurisprudence
Arkansas
United States
United States. Department of Health and Human Services

77. Arthroscopy pump tubing sets intended for multiple patient use - Premarket Notification (510(k)) submissions: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, December 23, 2021

Subject(s):

Arthroscopy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

78. Artificial intelligence in health care: benefits and challenges of machine learning technologies for medical diagnostics : report to congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, September 2022

Subject(s):

Artificial Intelligence -- legislation & jurisprudence
Diagnosis, Computer-Assisted -- legislation & jurisprudence
Government Regulation
Health Policy
Legislation, Medical
United States

79. As funding for BPA research increased, NIEHS followed its peer review process while also exercising its discretion

Publication:

[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2017

Subject(s):

Peer Review
Phenols -- adverse effects
Research -- economics
Federal Government
Financing, Government
Humans
United States
United States. Department of Health and Human Services.
National Institutes of Health (U.S.)

80. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2020

Subject(s):

Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

81. Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, November 17, 2023

Subject(s):

Computer Simulation
Device Approval
Government Regulation
United States

82. Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2022

Subject(s):

Administration, Oral
Drug Approval
Drugs, Investigational
Food-Drug Interactions
Government Regulation
United States
United States. Food and Drug Administration

83. Assessing user fees under the Biosimilar User Fee Amendments of 2017

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, January 2020

Subject(s):

Biosimilar Pharmaceuticals -- economics
Drug Development -- economics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

84. Assessing user fees under the Generic Drug User Fee Amendments of 2017

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2022

Subject(s):

Drug Industry -- legislation & jurisprudence
Drugs, Generic -- economics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

85. Assessing user fees under the Prescription Drug User Fee Amendments of 2017

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2018

Subject(s):

Fees and Charges
Investigational New Drug Application -- economics
Prescription Drugs -- economics
Biological Products -- economics
Orphan Drug Production -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

86. Assessing user fees under the biosimilar user fee amendments of 2017

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2018

Subject(s):

Biosimilar Pharmaceuticals -- economics
Fees and Charges
Investigational New Drug Application -- economics
Drug Evaluation -- economics
Parenteral Nutrition Solutions -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

87. Assessing user fees under the prescription drug user fee amendments of 2017

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, November 2020

Subject(s):

Drug Approval
Prescription Drugs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

88. Associations between county-level vaccination rates and COVID-19 outcomes among Medicare beneficiaries

Author(s):

Samson, Lok Wong, author
Tarazi, Wafa, author
Orav, E. J. (Endel John), author
Sheingold, Steven, author
De Lew, Nancy, author
Sommers, Benjamin D., author

Publication:

Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, October 5, 2021

Subject(s):

COVID-19 -- mortality
COVID-19 Vaccines -- therapeutic use
Hospitalization -- statistics & numerical data
Local Government
Medicare -- statistics & numerical data
Outcome Assessment, Health Care
Vaccination -- statistics & numerical data
United States

89. Associations between county-level vaccination rates and COVID-19 outcomes among Medicare beneficiaries

Author(s):

Samson, Lok Wong, author
Tarazi, Wafa, author
Orav, E. John, author
Sheingold, Steven, author
De Lew, Nancy, author
Sommers, Benjamin D., author

Publication:

Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, October 5, 2021

Subject(s):

COVID-19 -- epidemiology
COVID-19 Vaccines
Medicare
Outcome and Process Assessment, Health Care
Local Government
United States
United States. Department of Health and Human Services.

90. Availability of supplemental benefits in Medicare Advantage plans in rural and urban areas

Author(s):

Semprini, Jason, author
Ullrich, Fred, author
Mueller, Keith J., author

Publication:

Iowa City, IA : Rural Policy Research Institute, February 2021

Subject(s):

Insurance Benefits -- statistics & numerical data
Medicare Part C -- statistics & numerical data
Rural Population
Urban Population
United States

91. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, February 2018

Subject(s):

Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
Biological Products -- therapeutic use
Chemistry, Pharmaceutical
Mycobacterium bovis
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

92. BPC’s key considerations for developing a Medicaid home and community-based services benefit

Publication:

[Washington, DC] : Bipartisan Policy Center, June 15, 2021

Subject(s):

Community Health Services
Health Policy
Home Care Services
Medicaid
United States

93. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, September 2019

Subject(s):

Bacteriological Techniques
Blood Banks -- standards
Blood Platelets -- microbiology
Blood Preservation -- standards
Platelet Transfusion -- standards
Transfusion Reaction -- prevention & control
Product Labeling -- standards
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

94. Bacterial vaginosis: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, August 2019

Subject(s):

Clinical Trials as Topic
Drug Development
Vaginosis, Bacterial -- drug therapy
Pharmacokinetics
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

95. Basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020

Subject(s):

Accreditation
Electricity
Equipment Safety
Equipment and Supplies
Mechanical Tests
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

96. Behavioral health and COVID-19: higher-risk populations and related federal relief funding : report to congressional committees

Publication:

Washington, DC : United States Government Accountability Office, December 2021

Subject(s):

COVID-19 -- psychology
Government Regulation
Mental Health Services -- legislation & jurisprudence
Pandemics -- economics
Vulnerable Populations -- legislation & jurisprudence
United States

97. Behavioral health diagnoses and treatment services for children and youth involved with the child welfare system

Author(s):

Radel, Laura, author
Lieff, Sarah, author
Couzens, Chandra, author
Ali, Mir M., (Health economist) author
West, Kristina, (Of Office of the Assistant Secretary for Planning and Evaluation), author

Publication:

Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Human Services Policy, October 2023

Subject(s):

Adolescent
Child
Child Behavior Disorders -- drug therapy
Child Welfare -- statistics & numerical data
Mental Health Services -- statistics & numerical data
Prescription Drug Overuse -- statistics & numerical data
Psychotropic Drugs -- therapeutic use
State Government
United States

98. Behavioral health in rural America: challenges and opportunities

Author(s):

Gale, John, author
Janis, Jaclyn, author
Coburn, Andrew, author
Rochford, Hanna, author

Publication:

[Iowa City, Iowa] : Rural Policy Research Institute, December 2019

Subject(s):

Health Services Accessibility
Mental Disorders -- epidemiology
Mental Disorders -- therapy
Mental Health Services
Rural Health Services
Substance-Related Disorders -- epidemiology
Substance-Related Disorders -- therapy
Rural Population
United States

99. Behavioral health: Available workforce information and federal actions to help recruit and retain providers : report to congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, October 2022

Subject(s):

Behavioral Medicine -- organization & administration
Behavioral Medicine -- statistics & numerical data
Government Regulation
Health Personnel
Health Workforce -- organization & administration
Health Workforce -- statistics & numerical data
Legislation, Medical
Mental Health Services
Personnel Selection -- organization & administration
Personnel Selection -- statistics & numerical data
United States
United States. Department of Health and Human Services

100. Benefit-risk assessment for new drug and biological products: guidance for industry

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023

Subject(s):

Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Pharmaceutical Preparations
Risk Assessment
United States