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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
- Subject(s):
- Bone Density Conservation Agents -- therapeutic use
Drug Evaluation, Preclinical -- standards
Osteoporosis -- drug therapy
Anabolic Agents
Biological Products
Bone Density
Research Design
Toxicity Tests -- standards
Animals
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 2019
- Subject(s):
- Double-Blind Method
Neoplasms -- drug therapy
Placebos
Randomized Controlled Trials as Topic -- standards
Single-Blind Method
Antineoplastic Agents
Biological Products
Randomized Controlled Trials as Topic -- ethics
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, August 30, 2019
- Subject(s):
- Cost-Benefit Analysis
Device Approval
Equipment and Supplies -- classification
Equipment Safety -- classification
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, 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.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
- Subject(s):
- Chromatography -- standards
Drug Approval
Quality Control
Reference Standards
Calibration
Chemistry Techniques, Analytical
Investigational New Drug Application
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, September 2019
- Subject(s):
- Anticonvulsants -- therapeutic use
Clinical Trials as Topic
Drug Development -- standards
Seizures -- drug therapy
Adolescent
Anticonvulsants -- pharmacology
Child
Child, Preschool
Safety
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, September 6, 2019
- Subject(s):
- Compassionate Use Trials -- standards
Device Approval -- standards
Cost-Benefit Analysis
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, September 13, 2019
- Subject(s):
- Device Approval -- standards
Therapeutic Equivalency
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, September 2019
- Subject(s):
- Drug Approval -- legislation & jurisprudence
Investigational New Drug Application -- legislation & jurisprudence
Public Health -- legislation & jurisprudence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
- Subject(s):
- Commerce -- legislation & jurisprudence
Legislation, Drug
Pharmaceutical Preparations -- standards
Drug Labeling
Drug Packaging
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
