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Publication:
Washington, D.C. : U.S. Government Accountability Office, January 2017
Subject(s):
Child Welfare
Drug Utilization -- statistics & numerical data
Foster Home Care
Inappropriate Prescribing -- prevention & control
Psychotropic Drugs -- therapeutic use
Child
Government Regulation
Information Dissemination
Interinstitutional Relations
State Government
Humans
United States
United States. Department of Health and Human Services.
Publication:
Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):
Civil Defense
Interinstitutional Relations
Pandemics
Disaster Planning
Federal Government
Humans
United States
United States. Department of Defense.
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
Publication:
Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):
Community Health Services
Community-Institutional Relations
Interinstitutional Relations
Substance-Related Disorders -- prevention & control
Adolescent
Financing, Government
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2017
Subject(s):
Emergency Medical Services -- legislation & jurisprudence
Emergency Responders -- legislation & jurisprudence
Pharmaceutical Preparations -- supply & distribution
Drug Therapy
Legislation, Drug
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, April 2017
Subject(s):
Automatic Data Processing -- standards
Investigational New Drug Application
Drug Approval -- legislation & jurisprudence
Drug Approval -- organization & administration
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
Publication:
Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017
Subject(s):
Civil Defense -- legislation & jurisprudence
Device Approval
Drug Approval
Emergencies
Terrorism
Emergency Medical Services
Equipment Safety
Off-Label Use
Public Health
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Food and Drug Administration.
Publication:
Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017
Subject(s):
Device Approval
Drug Approval
Investigational New Drug Application
Access to Information
Clinical Trials as Topic
Drugs, Investigational
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, June 2017
Subject(s):
Arrhythmias, Cardiac -- chemically induced
Arrhythmias, Cardiac -- diagnosis
Cardiac Electrophysiology -- methods
Cardiac Electrophysiology -- standards
Drug Approval
Electrocardiography -- standards
Long QT Syndrome -- chemically induced
Cardiotoxins
Clinical Trials as Topic
Congresses as Topic
Diagnosis, Computer-Assisted
Drug-Related Side Effects and Adverse Reactions
International Cooperation
Pharmaceutical Preparations -- administration & dosage
Reference Standards
Research Design
Sex Factors
Humans
Europe
Japan
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, [June 2017]
Subject(s):
Chemistry, Pharmaceutical -- standards
Drug Compounding -- standards
Solvents -- classification
Congresses as Topic
International Cooperation
Solvents -- adverse effects
Humans
Europe
Japan
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 2017
Subject(s):
Clinical Trials as Topic -- standards
Human Experimentation -- standards
Informed Consent -- standards
Ethics Committees, Research
Ethics, Research
Informed Consent -- ethics
Research Subjects
Risk
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 2017
Subject(s):
Drug Approval
Investigational New Drug Application
Drugs, Investigational
Clinical Trials as Topic
Congresses as Topic
International Cooperation
Humans
Europe
Japan
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 2017
Subject(s):
Anti-Infective Agents, Local
Consumer Product Safety
Hand Sanitizers
Nonprescription Drugs
Anti-Bacterial Agents
Anti-Infective Agents, Local -- adverse effects
Soaps
Triclosan
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 2017
Subject(s):
Drug Approval
Drug Industry -- standards
Drugs, Generic
Guideline Adherence
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, 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:
Silver Spring, MD : Center for Devices and Radiological Health, August 29, 2017
Subject(s):
Device Approval
Small Business
Eligibility Determination
Taxes
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 31, 2017
Subject(s):
Equipment and Supplies
Equipment Safety
Evidence-Based Medicine
Product Surveillance, Postmarketing
Data Collection
Data Interpretation, Statistical
Decision Making
Device Approval
Quality Control
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 1, 2017
Subject(s):
Advisory Committees -- organization & administration
Device Approval
Equipment and Supplies -- 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, September 6, 2017
Subject(s):
Equipment and Supplies -- standards
Equipment Design -- standards
Equipment Safety -- standards
Device Approval
Equipment Failure
Information Dissemination
Risk Management
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 12, 2017
Subject(s):
Clinical Trials as Topic
Demography
Device Approval
Research Design
Age Factors
Continental Population Groups
Ethnic Groups
Product Surveillance, Postmarketing
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 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 Drug Evaluation and Research, September 2017
Subject(s):
Chemistry, Pharmaceutical
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Sulfur
Humans
Europe
Japan
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):
Chemistry, Pharmaceutical
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
Infusions, Parenteral
International Cooperation
Humans
Europe
Japan
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):
Drug Approval
Drug Contamination
Particulate Matter
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
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 2010
Subject(s):
Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
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):
Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
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):
Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Humans
Europe
Japan
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):
Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Capsules
Congresses as Topic
International Cooperation
Tablets
Humans
Europe
Japan
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):
Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
International Cooperation
Tablets
Humans
Europe
Japan
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):
Drug Approval
Pharmacopoeias as Topic -- standards
Congresses as Topic
Electrophoresis, Polyacrylamide Gel
International Cooperation
Humans
Europe
Japan
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):
Access to Information
Electronic Health Records
Medicare
Government Programs
Patient Participation
Program Evaluation
Humans
United States
United States. Department of Health and Human Services.
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:
Washington, D.C. : U.S. Government Accountability Office, March 2017
Subject(s):
Financial Audit
Fraud -- prevention & control
Insurance, Health, Reimbursement
Medicaid -- economics
Program Evaluation
Contract Services
Managed Care Programs
State Government
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
Publication:
Washington, D.C. : U.S. Government Accountability Office, March 2017
Subject(s):
Emergency Medical Services -- statistics & numerical data
Health Services Accessibility
Outcome Assessment (Health Care)
Pediatrics
Trauma Centers
Wounds and Injuries -- therapy
Child
Financing, Government
Hospital Mortality
Humans
United States
United States. Department of Health and Human Services.
United States. Health Resources and Services Administration.
National Institutes of Health (U.S.)
Publication:
Washington, D.C. : U.S. Government Accountability Office, April 2017
Subject(s):
Health Services Accessibility
Medicare
Telemedicine
Telemetry
Insurance Coverage
Insurance, Health, Reimbursement
Medicaid
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
Publication:
Washington, D.C. : U.S. Government Accountability Office, 2017
Subject(s):
Health Expenditures
Medicaid -- economics
Pilot Projects
Cost Control
Federal Government
Government Regulation
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
Publication:
Washington, D.C. : U.S. Government Accountability Office, April 2017
Subject(s):
Health Status
Insurance Selection Bias
Medicare Part C -- statistics & numerical data
Government Regulation
Risk
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
Publication:
Washington, D.C. : U.S. Government Accountability Office, May 2, 2017
Subject(s):
Fraud -- prevention & control
Community Health Services -- economics
Home Care Services -- economics
Insurance, Health, Reimbursement
Medicaid -- economics
Community Health Services -- organization & administration
Data Collection
Government Regulation
Health Expenditures
Home Care Services -- organization & administration
Quality Assurance, Health Care
State Government
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):
Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Sterilization
Congresses as Topic
International Cooperation
Humans
Europe
Japan
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, May 2017
Subject(s):
Education, Medical, Graduate -- statistics & numerical data
Health Manpower
Physicians, Family -- education
Physicians, Family -- supply & distribution
Primary Health Care -- manpower
Education, Medical, Graduate -- trends
Forecasting
Medicine -- statistics & numerical data
Nurse Practitioners -- supply & distribution
Physician Assistants -- supply & distribution
Rural Health Services -- manpower
Urban Health Services -- manpower
Humans
United States
United States. Department of Health and Human Services.
Publication:
Washington, D.C. : U.S. Government Accountability Office, June 2017
Subject(s):
Economics, Hospital
Quality of Health Care
Reimbursement, Incentive
Value-Based Purchasing
Hospitals, Rural -- economics
Hospitals, Urban -- economics
Safety-net Providers -- economics
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
Publication:
Washington, D.C. : U.S. Government Accountability Office, July 2017
Subject(s):
Early Intervention (Education) -- economics
Early Intervention (Education) -- organization & administration
Education, Special
Child Development
Child, Preschool
Disabled Children -- education
Financing, Government
Government Programs
Schools, Nursery
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Labor.
United States. Department of the Interior.
Publication:
Washington, D.C. : U.S. Government Accountability Office, July 2017
Subject(s):
Durable Medical Equipment -- economics
Equipment Reuse -- economics
Insurance Coverage -- economics
Insurance, Health, Reimbursement
Medicare -- economics
Blood Glucose Self-Monitoring -- instrumentation
Continuous Positive Airway Pressure -- instrumentation
Cost Savings
Infusion Pumps -- economics
Negative-Pressure Wound Therapy -- instrumentation
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
Publication:
Washington, D.C. : U.S. Government Accountability Office, July 13, 2017
Subject(s):
Child Care
Child Development
Early Intervention (Education)
Interinstitutional Relations
Child, Preschool
Federal Government
Financing, Government
Infant
Humans
United States
United States. Department of Education.
United States. Department of Health and Human Services.
United States. Department of the Interior.
Publication:
Washington, D.C. : U.S. Government Accountability Office, September 2017
Subject(s):
Awareness
Communications Media
Information Dissemination -- methods
Public Health Administration
Disease Outbreaks
Information Technology
Interinstitutional Relations
Humans
United States
United States. Department of Health and Human Services.
Publication:
Washington, D.C. : U.S. Government Accountability Office, September 2017
Subject(s):
Firearms
Patient Education as Topic
Safety
Wounds, Gunshot -- epidemiology
Wounds, Gunshot -- mortality
Wounds, Gunshot -- prevention & control
Adolescent
Child
Community Networks
Consumer Product Safety
Counseling
Forecasting
Suicide -- prevention & control
Suicide -- statistics & numerical data
Suicide -- trends
Humans
United States
United States. Department of Health and Human Services.
Publication:
Washington, D.C. : U.S. Government Accountability Office, September 27, 2017
Subject(s):
Human Trafficking -- prevention & control
Human Trafficking -- statistics & numerical data
Indians, North American
Data Collection
Federal Government
Human Trafficking -- legislation & jurisprudence
Law Enforcement
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Department of Justice.
United States. Department of the Interior.
Publication:
Washington, D.C. : U.S. Government Accountability Office, October 2017
Subject(s):
Neonatal Abstinence Syndrome -- economics
Neonatal Abstinence Syndrome -- therapy
Infant, Newborn
Insurance Coverage -- economics
Medicaid -- economics
Mothers
Neonatal Abstinence Syndrome -- drug therapy
Opioid-Related Disorders
Patient Education as Topic
Pregnancy
Prenatal Care
Social Stigma
Substance-Related Disorders -- therapy
Humans
United States
United States. Department of Health and Human Services.
Publication:
Washington, D.C. : U.S. Government Accountability Office, October 2017
Subject(s):
Bioterrorism -- prevention & control
Civil Defense
Awareness
Biological Warfare
Data Collection
Information Dissemination
Public Health
Research
Humans
United States
United States. Department of Agriculture.
United States. Department of Defense.
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Environmental Protection Agency.
Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2017
Subject(s):
Dual MEDICAID MEDICARE Eligibility
Formularies as Topic
Insurance Coverage
Medicare Part D -- statistics & numerical data
Drug Utilization
Medicare Part D -- economics
Humans
United States
United States. Department of Health and Human Services.
United States.
Publication:
Silver Spring, MD : Center for Tobacco Products, October 2017
Subject(s):
Documentation -- standards
Tobacco Products -- standards
Drug Approval
Health
Terminology as Topic
Tobacco Products -- adverse effects
Tobacco Products -- toxicity
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, December 2017
Subject(s):
Registries -- standards
Tobacco Products -- standards
Manufacturing and Industrial Facilities -- standards
Product Labeling -- standards
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, February 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
Biological Products -- therapeutic use
Chemistry, Pharmaceutical
Mycobacterium bovis
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, February 2018
Subject(s):
Chemistry, Pharmaceutical -- classification
Chemistry, Pharmaceutical -- standards
Crystallization -- classification
Investigational New Drug Application
Biological Availability
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, February 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Muscular Dystrophies -- drug therapy
Muscular Dystrophy, Duchenne -- drug therapy
Drug Labeling -- standards
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Publication:
[Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018
Subject(s):
Equipment and Supplies -- classification
Drugs, Investigational -- classification
Investigational New Drug Application
Pharmaceutical Preparations -- classification
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, February 2018
Subject(s):
Clinical Trials as Topic
Drug Evaluation -- standards
Migraine Disorders -- drug therapy
Acute Disease
Adult
Child
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, February 2018
Subject(s):
Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Biological Products -- standards
Congresses as Topic
Drug Approval
Drug Contamination
International Cooperation
Quality Control
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, March 2018
Subject(s):
Clinical Trials as Topic -- ethics
Clinical Trials as Topic -- methods
Ethics Committees, Research
Informed Consent
Randomized Controlled Trials as Topic -- ethics
Randomized Controlled Trials as Topic -- methods
Research Design
Research Subjects
Humans
Europe
Japan
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, March 2018
Subject(s):
Carcinogenicity Tests -- standards
Carcinogens
Chemistry, Pharmaceutical
DNA Damage -- genetics
Drug Contamination -- prevention & control
Mutagenicity Tests -- standards
Mutagens
Acrylonitrile -- toxicity
Aniline Compounds -- toxicity
Benzyl Compounds -- toxicity
Bis(Chloromethyl) Ether -- toxicity
Ethyl Chloride -- toxicity
Hydrazines -- toxicity
Hydrogen Peroxide -- toxicity
Methyl Chloride -- toxicity
Nitrobenzenes -- toxicity
No-Observed-Adverse-Effect Level
Quality Control
Toxicity Tests -- 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, March 2018
Subject(s):
Data Collection -- standards
Genomics -- standards
Specimen Handling -- standards
Confidentiality
Genetic Testing
Genotyping Techniques
Information Management -- standards
Informed Consent
International Cooperation
Privacy
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, March 2018
Subject(s):
Patient Outcome Assessment
Patient Reported Outcome Measures
Pulmonary Disease, Chronic Obstructive -- therapy
Surveys and Questionnaires
Clinical Trials as Topic
Outcome Assessment (Health Care)
Self-Assessment
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, April 2018
Subject(s):
Drug Compounding -- standards
Liposomes -- chemistry
Liposomes -- pharmacokinetics
Biological Availability
Chemistry, Pharmaceutical
Liposomes -- administration & dosage
Liposomes -- therapeutic use
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, April 2018
Subject(s):
Clinical Trials as Topic -- ethics
Drug Compounding -- standards
Pediatrics
Pharmaceutical Preparations
Child
Excipients
Infant
Infant, Newborn
International Cooperation
Models, Theoretical
Pharmaceutical Preparations -- administration & dosage
Taste
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, 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 Tobacco Products, Food and Drug Administration, April 2018
Subject(s):
Tobacco Products -- standards
Manufactured Materials -- standards
Tobacco
Tobacco Industry -- standards
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, April 2018
Subject(s):
Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Quality Control
Drug Contamination
Drug Labeling -- standards
International Cooperation
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, April 2018
Subject(s):
Clinical Protocols -- standards
Clinical Trials as Topic -- standards
Drug Approval
Drug Evaluation, Preclinical -- standards
Research Design
Carcinogenicity Tests -- 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, April 2018
Subject(s):
Clinical Trials as Topic -- standards
Diagnostic Imaging -- standards
Endpoint Determination -- standards
Research Design -- standards
Observer Variation
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):
Fees and Charges
Investigational New Drug Application -- economics
Prescription Drugs -- economics
Biological Products -- economics
Orphan Drug Production -- economics
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):
Blood Specimen Collection -- methods
Drug Evaluation, Preclinical -- methods
Pharmaceutical Preparations -- administration & dosage
Sample Size
Toxicity Tests -- methods
Toxicokinetics
Pharmacokinetics
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, May 2018
Subject(s):
Drug Compounding -- standards
Drug Industry -- standards
Contract Services
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, May 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Endpoint Determination
Hypogonadism -- drug therapy
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, 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 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, May 2018
Subject(s):
Health Policy
Marketing
Sunscreening Agents
Consumer Product Safety
Product Labeling
Sun Protection Factor
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, May 2018
Subject(s):
Anti-Bacterial Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation -- standards
Drugs, Investigational -- pharmacokinetics
Intraabdominal Infections -- drug therapy
Microbiological Techniques -- standards
Drug Labeling -- standards
Endpoint Determination -- standards
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 Drug Evaluation and Research, June 2018
Subject(s):
Anti-Bacterial Agents -- therapeutic use
Anti-Infective Agents, Urinary -- therapeutic use
Clinical Trials as Topic -- standards
Drug Evaluation
Microbiological Techniques -- standards
Urinary Tract Infections -- drug therapy
Endpoint Determination -- standards
Research Design -- standards
Urinary Tract Infections -- complications
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, June 2018
Subject(s):
Communication
Drug Labeling -- standards
Product Labeling -- standards
Equipment and Supplies -- standards
Pharmaceutical Preparations -- 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, June 2018
Subject(s):
Communication
Equipment and Supplies -- economics
Insurance, Health, Reimbursement -- economics
Pharmaceutical Preparations -- economics
Truth Disclosure
Costs and Cost Analysis
Device Approval
Drug Approval
Drug Industry
Information Dissemination
Outcome Assessment (Health Care) -- economics
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, June 15, 2018
Subject(s):
Electronic Health Records
Health Information Interoperability
Logical Observation Identifiers Names and Codes
Reagent Kits, Diagnostic
Device Approval
In Vitro Techniques -- 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, June 2018
Subject(s):
Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Antineoplastic Agents -- toxicity
Drug Approval
Drug Contamination
Research Design
Toxicity Tests
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, June 2018
Subject(s):
Biosimilar Pharmaceuticals -- economics
Fees and Charges
Investigational New Drug Application -- economics
Drug Evaluation -- economics
Parenteral Nutrition Solutions -- economics
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):
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 Biologics Evaluation and Research, July 2018
Subject(s):
Blood Component Transfusion
Blood Safety -- standards
Blood Transfusion
Zika Virus Infection -- blood
Zika Virus Infection -- transmission
Blood Donors
Zika Virus Infection -- epidemiology
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
Drug Evaluation
Research Design
Demography
Endpoint Determination
International Cooperation
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, July 2018
Subject(s):
Biosimilar Pharmaceuticals
Drug Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Publication:
Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):
Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
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):
Product Labeling -- standards
Tobacco Products -- standards
Tobacco Industry -- 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, 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:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):
Chemistry, Pharmaceutical
Drug Liberation
Solubility
Dosage Forms
Therapeutic Index, Drug
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 Liberation
Mastication
Quality Control
Solubility
Tablets -- pharmacokinetics
Drug Approval
Drug Labeling
Hardness
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, August 2018
Subject(s):
Drug Evaluation, Preclinical
Radiopharmaceuticals -- administration & dosage
Radiopharmaceuticals -- pharmacokinetics
Diagnostic Imaging
Diagnostic Uses of Chemicals
Radiopharmaceuticals -- toxicity
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):
Drug Evaluation, Preclinical
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Research Design
Software
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 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, September 2018
Subject(s):
Clinical Trials as Topic
Drug Evaluation
Rhinitis -- drug therapy
Adult
Chemistry, Pharmaceutical
Child
Patient Selection
Pediatrics
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 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.
Publication:
Silver Spring, MD : Office of Combination Products, Food and Drug Administration, September 2017
Subject(s):
Biological Products -- classification
Classification -- methods
Equipment and Supplies -- classification
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.