Subjects: United States / Recently Added: Within 3 Months - Digital Collections - National Library of Medicine Search Results

Start Over Subjects United States ✖ Recently Added Within 3 Months ✖

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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.)

18. 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

19. 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.

20. 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

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