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Start Over Subjects Humans ✖Remove constraint Subjects: Humans Subjects Research Design ✖Remove constraint Subjects: Research Design

31. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):
Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

32. Investigational enzyme replacement therapy products: nonclinical assessment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2019
Subject(s):
Drug Evaluation, Preclinical -- standards
Enzyme Replacement Therapy -- standards
Models, Animal
Research Design
Safety
Toxicity Tests -- standards
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

33. Smallpox (variola virus) infection: developing drugs for treatment or prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
Subject(s):
Clinical Trials as Topic
Drug Development -- standards
Smallpox -- drug therapy
Smallpox -- prevention & control
Antiviral Agents -- pharmacology
Antiviral Agents -- therapeutic use
Drug Evaluation, Preclinical
Emergencies
Investigational New Drug Application
Models, Animal
Orthopoxvirus
Public Health
Research Design
Safety
Toxicity Tests
Variola virus
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

34. Adaptive designs for clinical trials of drugs and biologics

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
Subject(s):
Adaptive Clinical Trials as Topic -- standards
Investigational New Drug Application
Adaptive Clinical Trials as Topic -- ethics
Biological Products
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

35. Assessing the usability of encounter data for enrollees in comprehensive managed care 2010-2011

Author(s):
Byrd, Vivian L.H., author
Dodd, Allison Hedley, author
Publication:
Princeton, NJ : Mathematica Policy Research, Inc., August 2015
Subject(s):
Comprehensive Health Care
Data Collection
Data Mining
Datasets as Topic
Episode of Care
Managed Care Programs
Medicaid -- statistics & numerical data
Quality Indicators, Health Care
Research Design
Humans
United States
Centers for Medicare & Medicaid Services (U.S.)