Recently Added: Within 6 Months and Within 1 Month / Dates by Range: 2000 and later - Digital Collections - National Library of Medicine Search Results

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1. CBO’s analysis of the long-term budgetary outlook: presentation at the University of Michigan’s 71st Annual Economic Outlook Conference

Author(s):: Dahl, Molly W., author
Publication:: [Washington, D.C.] : Congressional Budget Office, November 16, 2023
Subject(s):: Budgets -- trends
Federal Government
Forecasting
Health Care Costs -- trends
United States

2. Voluntary consensus standards recognition program for regenerative medicine therapies: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):: Drug Industry
Government Regulation
Reference Standards
Regenerative Medicine -- legislation & jurisprudence
Regenerative Medicine -- standards
Voluntary Programs
United States
Center for Biologics Evaluation and Research (U.S.)

3. Development and licensure of vaccines to prevent COVID-19: guidance for industry

Publication:: [Silver Spring, MD] : Center for Biologics Evaluation and Research, October 2023
Subject(s):: COVID-19 Vaccines -- standards
Drug Development
Drug Industry
Government Regulation
Vaccine Development
United States

4. 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

5. Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 19, 2023
Subject(s):: Equipment Safety
Government Regulation
Guideline Adherence
Monitoring, Physiologic
Remote Sensing Technology
United States

6. Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):: Blood Banking -- standards
Blood Donation -- standards
Blood Donors
Donor Selection -- standards
Government Regulation
Guideline Adherence
Plasma
United States

7. Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2023
Subject(s):: 2-Propanol -- analysis
Drug Compounding -- standards
Drug Contamination -- prevention & control
Drug Industry
Ethanol -- analysis
Government Regulation
Methanol -- poisoning
United States

8. Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2023
Subject(s):: Biological Products -- administration & dosage
Drug Dosage Calculations
Drug Industry
Drug Labeling
Drug Packaging
Government Regulation
Injections -- standards
Prescription Drugs -- administration & dosage
Product Labeling
Product Packaging
United States

9. Real-time oncology review (RTOR): guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2023
Subject(s):: Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Neoplasms -- drug therapy
United States

10. Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
Subject(s):: Clinical Trials as Topic
Drug Development
Drug Industry
Government Regulation
Outcome Assessment, Health Care
United States

11. Submitting patient-reported outcome data in cancer clinical trials: guidance for industry : technical specifications document

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
Subject(s):: Clinical Trials as Topic
Drug Development
Drug Industry
Government Regulation
Neoplasms -- drug therapy
Patient Reported Outcome Measures
United States

12. Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 3, 2023
Subject(s):: Device Approval
Government Regulation
Guideline Adherence
Thermometers -- standards
United States

13. Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2, 2023
Subject(s):: Compassionate Use Trials
Device Approval
Government Regulation
Guideline Adherence
United States

14. The Bipartisan Safer Communities Act: where things stand on the Medicaid and CHIP provisions

Author(s):: Dwyer, Anne, (Of Georgetown University. Center for Children and Families), author
Publication:: [Washington, DC] : Georgetown University Health Policy Institute, Center for Children and Families, August 2023
Subject(s):: Behavioral Medicine
Health Policy
Health Services Accessibility
Medicaid
Mental Health Services
Social Determinants of Health
United States
United States.
Children's Health Insurance Program (U.S.)

15. Medicaid support for infant and early childhood mental health: lessons from five states

Author(s):: Johnson, Kay, (Of Georgetown University. Center for Children and Families), author
Burak, Elizabeth Wright, author
Publication:: [Washington, DC] : Georgetown University Health Policy Institute, Center for Children and Families, September 2023
Subject(s):: Child Health
Health Services Accessibility
Infant Health
Mental Health Services
Medicaid
Socioeconomic Disparities in Health
State Health Plans
California
Colorado
Michigan
North Carolina
Washington

16. Medicaid managed care, maternal mortality review committees, and maternal health: a 12-state scan

Author(s):: Schneider, Andy, author
Mondestin, Tanesha, author
Mathews, Ella, author
Akinniyi, Eni, author
Publication:: [Washington, DC] : Georgetown University Health Policy Institute, Center for Children and Families, October 2023
Subject(s):: Advisory Committees
Managed Care Programs
Maternal Health
Maternal Mortality
Medicaid
Quality Improvement
Socioeconomic Disparities in Health
State Health Plans
Georgia
Illinois
Iowa
Kansas
Kentucky
Michigan
Mississippi
Nevada
New Jersey
New Mexico
Tennessee
Washington

17. Medicaid’s pandemic-era continuous coverage protections helped reduce number of uninsured children

Author(s):: Alker, Joan, author
Osorio, Aubrianna, author
Publication:: [Washington, DC] : Georgetown University Health Policy Institute, Center for Children and Families, November 2023
Subject(s):: Child
Medicaid
Medically Uninsured -- statistics & numerical data
Socioeconomic Disparities in Health
United States

18. Notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2023
Subject(s):: Correspondence as Topic
Device Approval
Government Regulation
Manufacturing Industry
United States
United States.

19. 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

20. Income of working-age veterans receiving disability compensation

Author(s):: Bass, Elizabeth, (Economist), author
Golding, Heidi L. W., author
Publication:: [Washington, D.C.] : Congressional Budget Office, December 2023
Subject(s):: Disabled Persons -- statistics & numerical data
Income -- statistics & numerical data
Insurance, Disability -- statistics & numerical data
Veterans -- statistics & numerical data
United States

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