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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 13, 2018
- Subject(s):
- Genetic Testing
Germ-Line Mutation
Diagnostic Test Approval
Reagent Kits, Diagnostic -- standards
Sequence Analysis, DNA
Genomics
Reproducibility of Results
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, April 13, 2018
- Subject(s):
- Databases, Genetic
Reagent Kits, Diagnostic -- standards
Reproducibility of Results
Access to Information
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
- Subject(s):
- Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
Biomarkers
Documentation
Dried Blood Spot Testing -- standards
Investigational New Drug Application
Quality Control
Reagent Kits, Diagnostic -- standards
Sensitivity and Specificity
Specimen Handling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
- Subject(s):
- Clinical Trials as Topic
Electronic Health Records -- utilization
Health Information Interoperability
Forms and Records Control
Informed Consent
Reproducibility of Results
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
- Subject(s):
- Chemistry, Pharmaceutical
Drug Contamination
Quality Control
International Cooperation
Investigational New Drug Application
Reproducibility of Results
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- [Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2011
- Subject(s):
- Blood Glucose -- analysis
Delivery of Health Care -- methods
Diagnostic Equipment -- standards
Point-of-Care Systems -- standards
Blood Glucose -- drug effects
Communication
Diagnostic Errors -- adverse effects
Diagnostic Errors -- prevention & control
Inpatients
Laboratories, Hospital
Organizational Policy
Patient safety
Physical Examination
Reagent Strips
Reference Values
Reproducibility of Results
Sensitivity and Specificity
Humans
Pennsylvania
United States
- Author(s):
- Pearson, Steven D., author
Ollendorf, Daniel A., author
Colby, Jennifer A., author
- Publication:
- [Boston, MA] : Institute for Clinical and Economic Review, [2012]
- Subject(s):
- Alzheimer Disease -- diagnosis
Diagnostic Tests, Routine -- methods
Evidence-Based Practice
Insurance Coverage
Biomarkers
Biomedical Research -- methods
Clinical Protocols
Clinical Trials as Topic -- methods
Early Diagnosis
Insurance, Health
Neuropsychological Tests
Outcome Assessment (Health Care)
Patient Outcome Assessment
Policy Making
Practice Guidelines as Topic
Predictive Value of Tests
Prognosis
Randomized Controlled Trials as Topic
Reproducibility of Results
Translational Medical Research -- methods
Humans
United States
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017
- Subject(s):
- Device Approval
Papillomavirus Infections -- diagnosis
Reagent Kits, Diagnostic -- standards
Cervix Uteri -- cytology
Cervix Uteri -- virology
Equipment Failure
Equipment Safety
Genotyping Techniques -- standards
Mass Screening
Papillomaviridae -- classification
Papillomaviridae -- genetics
Quality Control
Reference Standards
Reproducibility of Results
Research Design
Specimen Handling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, December 5, 2017
- Subject(s):
- Computer-Aided Design -- standards
Device Approval
Manufactured Materials -- standards
Materials Testing -- standards
Printing, Three-Dimensional -- standards
Quality Control
Computer Security -- standards
Diagnostic Imaging
Models, Anatomic
Product Labeling -- standards
Reproducibility of Results
Software -- standards
Sterilization -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, December 8, 2017
- Subject(s):
- Equipment and Supplies -- standards
Reproducibility of Results
Software -- standards
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.