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21. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
Subject(s):
Device Approval -- standards
Clinical Protocols
Research Design
Telecommunications
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

22. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

23. Separating fact from fiction: recommendations for academic health centers on artificial and augmented intelligence

Publication:
Atlanta, GA : Woodruff Health Sciences Center, Emory University, [2019]
Subject(s):
Artificial Intelligence
Delivery of Health Care -- methods
Academic Medical Centers
Decision Support Techniques
Education, Medical -- methods
Electronic Health Records
Machine Learning
Research Design
Humans
United States

24. Calculation of outcome rates that diagnose bedside performance: central-line-associated bloodstream infection

Author(s):
Davis, James, author
Finley, Edward, author
Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, [2013]
Subject(s):
Bacteremia -- epidemiology
Bacteremia -- etiology
Catheter-Related Infections -- epidemiology
Catheter-Related Infections -- etiology
Catheterization, Central Venous -- adverse effects
Infection control
Medical Errors -- statistics & numerical data
Outcome Assessment (Health Care)
Research Design
Catheterization, Central Venous -- instrumentation
Electronic Health Records
Hospitals -- statistics & numerical data
Maintenance -- standards
Medical Errors -- prevention & control
Patient safety
Time Factors
Humans
Pennsylvania
United States

25. Meta-analysis of federally funded teen pregnancy prevention programs: technical supplement

Author(s):
Juras, Randall, author
Kelsey, Meredith, author
Lipsey, March, author
Steinka-Fry, Katarzyna, author
Layzer, Jean, author
Publication:
Washington, DC : Department of Health and Human Services, Office of Population Affairs, November 2019
Subject(s):
Government Programs
Pregnancy in Adolescence -- prevention & control
Research Design
Federal Government
United States

26. Meta-analysis of federally funded teen pregnancy prevention programs: final report

Author(s):
Juras, Randall, author
Kelsey, Meredith, author
Lipsey, Mark, author
Steinka-Fry, Katarzyna, author
Layzer, Jean, author
Publication:
Washington, DC : Department of Health and Human Services, Office of Population Affairs, November 2019
Subject(s):
Government Programs
Pregnancy in Adolescence -- prevention & control
Program Evaluation
Research Design
Federal Government
United States

29. Considerations for building federal data capacity for patient-centered outcomes research related to intellectual and developmental disabilities

Author(s):
Dhopeshwarkar, Rina, author
Heaney-Huls, Krysta, author
Hovey, Lauren, author
Leaphart, Desirae, author
Dullabh, Prashila, author
Publication:
Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, September 22, 2021
Subject(s):
Data Collection
Developmental Disabilities
Intellectual Disability
Patient-Centered Care
Research Design
United States
United States. Department of Health and Human Services.

30. Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Clinical Trials as Topic
Prognosis
Research Design
Biomarkers, Pharmacological
Biomarkers, Tumor
Captopril -- therapeutic use
Cardiovascular Diseases -- drug therapy
Clozapine -- therapeutic use
Cyclooxygenase 2 Inhibitors -- therapeutic use
Drugs, Investigational
Lung Diseases -- drug therapy
Medication Adherence
Neoplasms -- drug therapy
Patient Compliance
Patient Selection
Pharmacogenetics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.