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5401. Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry

Publication:

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

Subject(s):

Drug Approval
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration

5402. Homeopathic drug products: guidance for FDA staff and industry

Publication:

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

Subject(s):

Government Regulation
Homeopathy -- legislation & jurisprudence
Materia Medica
United States
United States. Food and Drug Administration

5403. Pharmacokinetic-based criteria for supporting alternative dosing regimens of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for treatment of patients with cancer: guidance for industry

Publication:

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

Subject(s):

Government Regulation
Immune Checkpoint Inhibitors -- administration & dosage
Immune Checkpoint Inhibitors -- pharmacokinetics
Programmed Cell Death 1 Receptor -- administration & dosage
United States
United States. Food and Drug Administration

5404. E19: a selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials : guidance for industry

Publication:

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

Subject(s):

Clinical Trials as Topic
Data Collection
Government Regulation
Patient Safety
United States
United States. Food and Drug Administration

5405. 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.

5406. Public health preparedness: HHS should address strategic national stockpile requirements and inventory risks : report to congressional addressees

Publication:

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

Subject(s):

Civil Defense -- statistics & numerical data
Government Regulation
Legislation, Medical
Strategic Stockpile -- organization & administration
United States
United States. Department of Health and Human Services

5407. How increased funding can advance the mission of the Indian Health Service to improve health outcomes for American Indians and Alaska Natives

Publication:

Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, July 2022

Subject(s):

American Indian or Alaska Native -- statistics & numerical data
Financing, Government
Health Status Disparities
Healthcare Disparities
Outcome Assessment, Health Care
United States
United States. Indian Health Service

5408. Racial and ethnic differences in children's mental health services in Medicaid before and during the COVID-19 pandemic

Author(s):

Ali, Mir M., (Health economist), author
West, Kristina D., author
Creedon, Timothy B., author

Publication:

Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Behavioral Health, Disability, and Aging Policy November 1, 2022

Subject(s):

Child
COVID-19
Ethnicity
Facilities and Services Utilization -- statistics & numerical data
Medicaid -- statistics & numerical data
Mental Health Services -- statistics & numerical data
Racial Groups
Telemedicine -- statistics & numerical data
United States

5409. Cross labeling oncology drugs in combination regimens: guidance for industry

Publication:

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

Subject(s):

Antineoplastic Combined Chemotherapy Protocols
Drug Labeling -- legislation & jurisprudence
Government Regulation
United States
United States. Food and Drug Administration

5410. Reductions in deaths and hospitalizations associated with COVID-19 vaccinations among Medicare beneficiaries: full year 2021 estimates

Author(s):

Samson, Lok Wong, author
Sayed, Bisma Ali, author
Orav, E. J. (Endel John), author
Sommers, Benjamin D., author

Publication:

Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, October 2022

Subject(s):

COVID-19 -- mortality
COVID-19 Vaccines
Hospitalization -- statistics & numerical data
Medicare -- statistics & numerical data
Vaccination -- statistics & numerical data
State Government
United States

5411. Cannabis and cannabis-derived compounds: quality considerations for clinical research : guidance for industry

Publication:

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

Subject(s):

Cannabis
Drug Development
Government Regulation
Medical Marijuana
United States
United States. Food and Drug Administration

5412. Changes in health insurance coverage, 2019-2021: geographic and demographic patterns in the uninsured rate

Author(s):

Lee, Aiden, author
Ruhter, Joel, author
Bosworth, Arielle, 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, Office of Health Policy, January 2023

Subject(s):

Insurance Coverage -- statistics & numerical data
Insurance Coverage -- trends
Medically Uninsured -- statistics & numerical data
Ethnicity
Racial Groups
State Government
United States

5413. Doula care and maternal health: an evidence review

Author(s):

Knocke, Kathleen, author
Chappel, Andre, author
Sugar, Sarah, 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, December 13, 2022

Subject(s):

Doulas
Maternal Health
Maternal Health Services
Evidence-Based Medicine
United States

5414. Analysis of alternative approaches to increasing Part B financial assistance to Medicare beneficiaries with low incomes

Author(s):

Gangopadhyaya, Anuj, author
Holahan, John, author
Shartzer, Adele, author
Garrett, Bowen, author

Publication:

Washington, DC : Urban Institute, December 2022

Subject(s):

Health Equity -- economics
Health Policy
Medicare Part B -- economics
Poverty -- statistics & numerical data
United States

5415. Mothers’ mental health challenges predated the COVID-19 pandemic

Author(s):

Haley, Jennifer M., author
McMorrow, Stacey, author
Long, Julia, (Of Urban Institute), author

Publication:

Washington, DC : Urban Institute, January 2023

Subject(s):

Health Equity -- economics
Health Policy
Mental Health -- statistics & numerical data
Mothers -- psychology
Socioeconomic Factors
United States

5416. Foreign supplier verification programs for importers of food for humans and animals: guidance for industry

Publication:

[Silver Spring, MD] : Office of Regulatory Affairs, January 2023

Subject(s):

Animal Feed -- standards
Animal Feed -- supply & distribution
Food Safety
Food Supply -- legislation & jurisprudence
Food Supply -- standards
Government Regulation
United States
United States. Food and Drug Administration

5417. Advancing maternal health equity in southern states: what are Medicaid programs doing and what more could they do?

Author(s):

Haley, Jennifer M., author
Hinojosa, Sofia, author
Lacy, Leandra, author
Willis, Carla, author

Publication:

Washington, DC : Urban Institute, November 2022

Subject(s):

Health Equity -- economics
Health Policy
Maternal Health -- statistics & numerical data
Medicaid -- legislation & jurisprudence
Southeastern United States
Southwestern United States

5418. Who would gain coverage under Medicaid expansion in North Carolina?

Author(s):

Simpson, Michael, (Of Urban Institute), author
Brett-Turner, Ella, author

Publication:

Washington, DC : Urban Institute, November 2022

Subject(s):

Health Equity -- economics
Health Policy
Medicaid -- organization & administration
Medically Uninsured -- statistics & numerical data
North Carolina

5419. Report on the affordability of insulin

Author(s):

Finegold, Kenneth, 1957- author
Sayed, Bisma A., author

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, December 16, 2022

Subject(s):

Costs and Cost Analysis
Drug Costs
Health Expenditures
Insulin -- economics
Diabetes Mellitus -- drug therapy
Diabetes Mellitus -- economics
Medication Adherence
United States

5420. How many people that receive one safety net benefit also receive others?

Author(s):

Macartney, Suzanne E., author
Ghertner, Robin, author

Publication:

Washington, DC : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Human Services Policy, January 20, 2023

Subject(s):

Public Assistance -- statistics & numerical data
Safety-net Providers -- statistics & numerical data
United States

5421. What are human services, and how do state governments structure them?

Author(s):

Hahn, Heather, author
Pratt, Eleanor, author
Lawrence, DaQuan, author
Aron, Laudan Y., author

Publication:

Washington, DC : Urban Institute, December 2022

Subject(s):

Health Equity -- economics
Health Policy
Social Welfare
State Government
United States

5422. How many people participate in the social safety net?

Author(s):

Macartney, Suzanne E., author
Ghertner, Robin, author

Publication:

Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Human Services Policy, January 20, 2023

Subject(s):

Public Assistance -- statistics & numerical data
Safety-net Providers -- statistics & numerical data
Adult
Child
United States

5423. 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.

5424. Who would gain coverage under Medicaid expansion in Georgia?

Author(s):

Simpson, Michael, (Of Urban Institute), author
Brett-Turner, Ella, author

Publication:

Washington, DC : Urban Institute, November 2022

Subject(s):

Health Equity -- economics
Health Policy
Medicaid -- organization & administration
Medically Uninsured -- statistics & numerical data
Georgia

5425. A framework for assessing equitable health outcomes of parks: guidance for park practitioners and local leaders

Author(s):

Burrowes, Kimberly, author
Trekson, Mark, author
Shakesprere, Jessica, author

Publication:

Washington, DC : Urban Institute, November 2022

Subject(s):

Environmental Health -- statistics & numerical data
Health Equity -- economics
Health Policy
Outcome Assessment, Health Care -- statistics & numerical data
Parks, Recreational -- economics
United States

5426. The impact of the COVID-19 public health emergency expiration on all types of health coverage

Author(s):

Buettgens, Matthew, author
Green, Andrew, (Of Urban Institute), author

Publication:

Washington, DC : Urban Institute, December 2022

Subject(s):

COVID-19 -- economics
Health Equity -- economics
Health Policy
Insurance Coverage -- economics
Medicaid -- statistics & numerical data
Medically Uninsured -- statistics & numerical data
United States

5427. Disparities in preventive care receipt in Washington, DC, during the coronavirus pandemic: a case study

Author(s):

Taylor, Kimá Joy, author
Benatar, Sarah, author
Mitchell, Faith, 1952- author
Liu, Jackie, (Of Urban Institute), author
Alvarez Caraveo, Clara, author

Publication:

Washington, DC : Urban Institute, January 2023

Subject(s):

COVID-19
Health Equity -- economics
Health Policy
Healthcare Disparities
Preventive Health Services -- supply & distribution
District of Columbia

5428. Which hospital financial characteristics are associated with medical debt?: hospital profitability, the provision of charity care, and medical debt in hospital markets

Author(s):

Gangopadhyaya, Anuj, author
Blavin, Fredric E., author
Braga, Breno, (Economist) author
Andre, Jennifer, author

Publication:

Washington, DC : Urban Institute, September 2022

Subject(s):

Charities -- economics
Charities -- organization & administration
Health Equity -- economics
Health Expenditures -- statistics & numerical data
Health Policy
Economics, Hospital
United States

5429. Findings from the first year of Medicaid managed care in North Carolina

Author(s):

Allen, Eva H., author
Verdeflor, Alaisha, author
Alvarez Caraveo, Clara, author

Publication:

Washington, DC : Urban Institute, October 2022

Subject(s):

Health Equity -- economics
Health Policy
Managed Care Programs -- organization & administration
Managed Care Programs -- statistics & numerical data
Medicaid -- legislation & jurisprudence
Medicaid -- organization & administration
North Carolina

5430. How should we measure and interpret racial and ethnic disparities in health care?

Author(s):

Clemans-Cope, Lisa, author
Garrett, Bowen, author
McMorrow, Stacey, author

Publication:

Washington, DC : Urban Institute, January 2023

Subject(s):

Health Equity -- economics
Health Policy
Healthcare Disparities -- ethnology
Racism -- prevention & control
Social Determinants of Health -- classification
United States

5431. Certified Community Behavioral Health Clinics demonstration program: report to Congress, 2020

Publication:

[Washington, D.C.] : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Behavioral Health, Disability, and Aging Policy, December 2021

Subject(s):

Community Mental Health Centers -- economics
Costs and Cost Analysis
Mental Health Services -- economics
Program Evaluation
Quality Indicators, Health Care
United States

5432. Data elements for research on the role of social determinants of health in Coronavirus disease 2019: infection and outcomes in the U.S

Author(s):

Kim, Katherine K., author
Qudsi, Hibah K., author
Halter, Heather M., author
Hogan, Katie, author
Hull, Susan C., author
Saltzman, Jaclyn A., author
Norton, Jenna, author
Lee, Euny, author
Haltermann, William, author
Grigorescu, Violanda, author

Publication:

Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, March 7, 2022

Subject(s):

COVID-19 -- epidemiology
Risk Factors
Social Determinants of Health
Comorbidity
United States

5433. Interim cost and qualiIty findings from the national evaluation of the Certified Community Behavioral Health Clinic demonstration

Author(s):

Breslau, Joshua, author
Briscombe, Brian, author
Dunbar, Michael Stephen, author
Kase, Courtney, author
Brown, Jonathan D. (Jonathan David), 1978- author
Siegwarth, Allison Wishon, author
Miller, Rachel, (Of Mathematica Policy Research),, author

Publication:

[Washington, D.C.] : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Behavioral Health, Disability, and Aging Policy, December 2021

Subject(s):

Costs and Cost Analysis
Community Mental Health Centers -- economics
Mental Health Services -- economics
Program Evaluation
Quality Indicators, Health Care
United States

5434. Linking state health care data to inform policymaking: opportunities and challenges

Publication:

Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, June 2022

Subject(s):

Data Collection -- methods
Databases as Topic
Health Policy
Policy Making
Routinely Collected Health Data
State Government
United States

5435. 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

5436. COVID-19 vaccination associated with reductions in COVID-19 mortality and morbidity in the United States, and an approach to valuing these benefits

Author(s):

Holtkamp, Nicholas, author
Kolbe, Allison, author
Beleche, Trinidad, author

Publication:

Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, December 2021

Subject(s):

COVID-19 -- epidemiology
COVID-19 -- mortality
COVID-19 Vaccines -- economics
Hospitalization -- statistics & numerical data
Insurance Coverage
Morbidity
United States

5437. 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
Samsom, Lok Wong, author
Sommers, Benjamin D., author

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, August 2022

Subject(s):

Cost Savings
COVID-19 -- economics
COVID-19 Drug Treatment
COVID-19 Vaccines -- economics
Insurance Coverage -- economics
Drug Approval
United States

5438. Veterans health care: VA actions needed to ensure timely scheduling of specialty care appointments : report to congressional committees

Publication:

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

Subject(s):

Appointments and Schedules
Government Regulation
Health Services Accessibility -- legislation & jurisprudence
Legislation, Medical
Referral and Consultation -- statistics & numerical data
Time Factors
Veterans Health Services -- legislation & jurisprudence
United States
United States. Department of Veterans Affairs

5439. 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.)

5440. Tracking the funds: specific fiscal year 2022 provisions for Department of Health and Human Services : report to congressional committees

Publication:

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

Subject(s):

Financing, Government -- organization & administration
Financing, Government -- standards
Government Regulation
Legislation, Medical
United States
United States. Department of Health and Human Services

5441. Medicare Advantage: Plans generally offered some supplemental benefits, but CMS has limited data on utilization : report to congressional committees

Publication:

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

Subject(s):

Government Regulation
Insurance, Medigap -- legislation & jurisprudence
Legislation, Medical
Medicare Part C -- statistics & numerical data
United States
United States. Department of Health and Human Services
Centers for Medicare & Medicaid Services (U.S.)

5442. Enhancing data infrastructure to improve women’s health outcomes

Publication:

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

Subject(s):

Data Collection
Outcome Assessment, Health Care
Registries
Women's Health
United States

5443. Recommendations to reduce the risk of transfusion-transmitted malaria: guidance for industry

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, December 2022

Subject(s):

Blood Banking -- methods
Blood-Borne Infections -- prevention & control
Government Regulation
Malaria -- prevention & control
Malaria -- transmission
United States
United States. Food and Drug Administration

5444. Institutional review boards: Actions needed to improve federal oversight and examine effectiveness : report to congressional requesters

Publication:

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

Subject(s):

Ethics Committees, Research -- legislation & jurisprudence
Government Regulation
Legislation, Medical
Research Subjects -- legislation & jurisprudence
Risk Assessment -- legislation & jurisprudence
United States

5445. Routine vaccinations: adult rates vary by vaccine type and other factors : report to congressional requesters

Publication:

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

Subject(s):

Adult
Government Regulation
Health Expenditures -- statistics & numerical data
Healthcare Disparities -- statistics & numerical data
Legislation, Medical
Vaccination Coverage -- statistics & numerical data
COVID-19
United States

5446. Surveying, leveling, and alignment laser products: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health , January 31, 2023

Subject(s):

Government Regulation
Lasers
Medical Device Legislation
Weights and Measures
United States
United States. Food and Drug Administration

5447. Integrating SUD and OB/GYN care: policy challenges and opportunities final report

Author(s):

Seibert, Julie (Julie Hayes), author
Dobbins, Erin, (Of RTI International), author
Theis, Elysha, author
Murray, Madeline, author
Stockdale, Holly, author
Feinberg, Rose, author
Hinde, Jesse M., author
Karon, Sarita L., author

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Behavioral Health, Disability, and Aging Policy, January 2022

Subject(s):

Delivery of Health Care, Integrated
Health Policy
Prenatal Care
Mental Health Services
Substance-Related Disorders -- therapy
United States

5448. Ownership of skilled nursing facilities: an analysis of newly-released federal data

Author(s):

Welch, W. Pete, author
Oliveira, Iara, author
Blanco, Martin, (Of the Office of Behavioral Health, Disability, and Aging Policy in ASPE), author
Sommers, Benjamin D., author

Publication:

Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, December 15, 2022

Subject(s):

Ownership -- statistics & numerical data
Skilled Nursing Facilities -- statistics & numerical data
United States

5449. The demographic outlook: 2023 to 2053

Author(s):

Crown, Daniel, (Of Congressional Budget Office), author

Publication:

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

Subject(s):

Birth Rate -- trends
Demography -- trends
Emigrants and Immigrants -- statistics & numerical data
Life Expectancy -- trends
Mortality -- trends
Population Forecast
United States

5450. Heat-related illness: a window into recent trends

Publication:

New York, NY : FAIR Health, Inc., December 13, 2022

Subject(s):

Heat Stress Disorders -- epidemiology
Age Factors
Global Warming
Sex Factors
United States