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Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):
Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
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):
Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- 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, October 2, 2017
Subject(s):
Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- 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, September 2017
Subject(s):
Biomedical Technology -- standards
Drug Industry -- standards
Inventions
Quality Assurance, Health Care
Quality Improvement
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
Subject(s):
Fraud -- prevention & control
Medicaid
Federal Government
State Government
Humans
Alaska
United States
United States. Department of Health and Human Services.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):
Clinical Trials as Topic
Drug Evaluation
Rhinitis, Allergic -- drug therapy
Adrenal Cortex Hormones -- therapeutic use
Adult
Child
Drug Combinations
Research Design
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, May 2018
Subject(s):
Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
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 2017
Subject(s):
Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Approval
Drug Resistance, Bacterial
Investigational New Drug Application
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Publication:
Washington, D.C. : U.S. Government Accountability Office, March 2017
Subject(s):
Anti-Bacterial Agents -- adverse effects
Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Resistance, Bacterial
Drug Resistance, Microbial
Food -- adverse effects
Food Inspection
Food Safety
Foodborne Diseases -- microbiology
Veterinary Drugs -- adverse effects
Veterinary Drugs -- therapeutic use
Bacterial Infections -- epidemiology
Cattle
Disease Outbreaks -- prevention & control
Foodborne Diseases -- epidemiology
Poultry
Swine
World health
Humans
Canada
Denmark
Netherlands
United States
United States. Department of Agriculture.
United States. Department of Health and Human Services.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):
Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.