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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