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Search Results
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
- Subject(s):
- Biological Products
Drug Approval
Licensure
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 16, 2019
- Subject(s):
- Device Approval -- standards
Equipment and Supplies -- standards
Manufactured Materials -- standards
Device Approval -- legislation & jurisprudence
Time Factors
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 Devices and Radiological Health, March 12, 2020
- Subject(s):
- Device Approval
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 Drug Evaluation and Research, September 2020
- Subject(s):
- Drug Approval
Drug Industry
Drugs, Generic
Therapeutic Equivalency
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 16, 2019
- Subject(s):
- Device Approval -- standards
Checklist
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Author(s):
- Johnson, Christian, MPH, author
Krakow, Melinda, author
Patel, Vaishali, author
- Publication:
- Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, January 2020
- Subject(s):
- Electronic Health Records -- statistics & numerical data
Facilities and Services Utilization -- statistics & numerical data
Health Services Accessibility -- statistics & numerical data
Neoplasms
United States
United States. Department of Health and Human Services.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
- Subject(s):
- Accreditation
Equipment and Supplies
Materials Testing
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, 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.
- 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:
- Washington, DC : United States Government Accountability Office, September 2018
- Subject(s):
- Financing, Government
Substance-Related Disorders -- prevention & control
Adolescent
Young Adult
United States
United States. Department of Education.
United States. Department of Health and Human Services.
United States. Department of Justice.
- 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 Biologics Evaluation and Research, April 2020
- Subject(s):
- Blood Donors
Blood Transfusion
Plasma
COVID-19
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):
- Amyotrophic Lateral Sclerosis -- drug therapy
Clinical Trials as Topic -- standards
Drug Development -- standards
Pharmacokinetics
Research Design -- standards
Safety
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.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2017
- Subject(s):
- Peer Review
Phenols -- adverse effects
Research -- economics
Federal Government
Financing, Government
Humans
United States
United States. Department of Health and Human Services.
National Institutes of Health (U.S.)
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
- Subject(s):
- Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
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, January 2020
- Subject(s):
- Biosimilar Pharmaceuticals -- economics
Drug Development -- economics
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, 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.
- Author(s):
- Samson, Lok Wong, author
Tarazi, Wafa, author
Orav, E. John, author
Sheingold, Steven, author
De Lew, Nancy, author
Sommers, Benjamin D., author
- Publication:
- Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, October 5, 2021
- Subject(s):
- COVID-19 -- epidemiology
COVID-19 Vaccines
Medicare
Outcome and Process Assessment, Health Care
Local Government
United States
United States. Department of Health and Human Services.
- 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 Biologics Evaluation and Research, September 2019
- Subject(s):
- Bacteriological Techniques
Blood Banks -- standards
Blood Platelets -- microbiology
Blood Preservation -- standards
Platelet Transfusion -- standards
Transfusion Reaction -- prevention & control
Product Labeling -- standards
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, August 2019
- Subject(s):
- Clinical Trials as Topic
Drug Development
Vaginosis, Bacterial -- drug therapy
Pharmacokinetics
Research Design
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 25, 2020
- Subject(s):
- Accreditation
Electricity
Equipment Safety
Equipment and Supplies
Mechanical Tests
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, December 2017
- Subject(s):
- Communication
Drug Industry
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, 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 Devices and Radiological Health, September 25, 2020
- Subject(s):
- Accreditation
Equipment and Supplies
Materials Testing -- standards
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, 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:
- Silver Spring, MD : Center for Biologics Evaluation and Research, March 2020
- Subject(s):
- Biological Products
Blood Banks -- standards
Mandatory Reporting
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 29, 2020
- Subject(s):
- Blood Glucose
Equipment Safety
Point-of-Care Testing
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, March 3, 2020
- Subject(s):
- Device Approval
Suture Anchors
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 29, 2020
- Subject(s):
- Breast Implants
Equipment Safety
Product Labeling
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, May 2017
- Subject(s):
- Government Regulation
Security Measures
Toxins, Biological
Federal Government
Laboratories -- standards
Risk Assessment
Risk Management
Humans
United States
United States. Department of Health and Human Services.
Centers for Disease Control and Prevention (U.S.)
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2018
- Subject(s):
- Durable Medical Equipment -- economics
Insurance, Health, Reimbursement
Medicare -- economics
Skilled Nursing Facilities
Home Care Services -- economics
Insurance Claim Review
Insurance Coverage
Medicaid -- economics
Nursing Homes
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, April 2017
- Subject(s):
- Economics, Hospital
Insurance, Health, Reimbursement
Quality Indicators, Health Care
Reimbursement, Incentive
Cross Infection
Inpatients
Mandatory Reporting
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, May 2020
- Subject(s):
- Biological Products
COVID-19 -- drug therapy
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
Investigational New Drug Application
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 2021
- Subject(s):
- Biological Products
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Drug Industry
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, August 2017
- Subject(s):
- Drug Costs
Insurance, Pharmaceutical Services -- economics
Medicare Part B -- economics
Cost Control
Cost Savings
Medicaid -- economics
Humans
United States
United States. Department of Health and Human Services.
- Publication:
- Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, July 2020
- Subject(s):
- Brain Neoplasms
Clinical Trials as Topic
Eligibility Determination
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
- Subject(s):
- Clinical Trials as Topic
Eligibility Determination
Neoplasms
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
- Subject(s):
- Clinical Trials as Topic
Hepatitis B
Hepatitis C
HIV
Neoplasms
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
- Subject(s):
- Clinical Trials as Topic
Eligibility Determination
Heart Failure
Liver Failure
Neoplasms
Renal Insufficiency
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 2019
- Subject(s):
- Child Health Services
Emigrants and Immigrants -- psychology
Mental Health Services
Refugees
Child
Health Services Accessibility
Mental Disorders -- therapy
Psychological Trauma -- therapy
Humans
United States
United States. Department of Health and Human Services.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, March 27, 2020
- Subject(s):
- Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
- Publication:
- [Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
- Subject(s):
- Device Approval -- standards
Documentation -- 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 Biologics Evaluation and Research September 2020
- Subject(s):
- Biomedical Research
Confidentiality
Privacy
Research Subjects
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 -- economics
State Government
Humans
United States
United States. Department of Health and Human Services.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
- Subject(s):
- Food Industry
Food Inspection
Food Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Author(s):
- Richwine, Chelsea, author
Marshall, Carmelita, author
Jensen, Christian, 1833-1916, author
Patel, Vaishali, author
- Publication:
- Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, September 2021
- Subject(s):
- Health Information Interoperability
Hospitals
Information Dissemination
Mandatory Reporting
Public Health
Public Health Surveillance
COVID-19
Health Facility Size
State Government
United States
United States. Department of Health and Human Services.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 27, 2019
- Subject(s):
- Equipment and Supplies -- standards
Software -- legislation & jurisprudence
Electronic Health Records
Healthy Lifestyle
Hospital Information Systems
Mobile Applications -- legislation & jurisprudence
Software -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
United States.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
- Subject(s):
- Chemistry, Pharmaceutical
Genetic Therapy
Investigational New Drug Application
Drugs, Investigational
Quality Control
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):
- Consumer Product Safety
Drug Labeling -- standards
Drug Packaging -- standards
Child
Nonprescription Drugs
Prescription Drugs
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, November 2017
- Subject(s):
- Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Hepatitis C, Chronic -- drug therapy
Antiviral Agents -- pharmacokinetics
Drugs, Investigational -- pharmacokinetics
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, 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, 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 : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
- Subject(s):
- Clinical Trials as Topic
Databases as Topic
Data Management -- legislation & jurisprudence
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 Devices and Radiological Health, April 1, 2019
- Subject(s):
- Bacillus
Equipment Safety
Reagent Kits, Diagnostic -- classification
Reagent Kits, Diagnostic -- standards
Bacteriophage Typing -- classification
Enzyme-Linked Immunosorbent Assay -- classification
Fluorescent Antibody Technique -- classification
Nucleic Acid Amplification Techniques -- 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, May 8, 2019
- Subject(s):
- Equipment Safety
Lasers -- classification
Lasers -- standards
Device Approval
Lasers -- adverse effects
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, May 4, 2020
- Subject(s):
- Bone Screws
Cervical Vertebrae
Classification
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- 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.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
- Subject(s):
- Drug Interactions
Clinical Trials as Topic
Cytochrome P-450 Enzyme System
Drugs, Investigational
Membrane Transport Proteins
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, July 15, 2020
- Subject(s):
- Clinical Studies as Topic
High-Intensity Focused Ultrasound Ablation
Prostate -- surgery
Prostatic Neoplasms -- prevention & control
Prostatic Neoplasms -- surgery
Therapies, Investigational
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:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, August 2017
- Subject(s):
- Fraud -- prevention & control
Medicaid
Federal Government
State Government
Humans
Colorado
United States
United States. Department of Health and Human Services.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
- Subject(s):
- Community-Acquired Infections
Drug Development
Pneumonia, Bacterial -- drug therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Author(s):
- Feng, Zhanlian, author
Wang, Feng, (College teacher in marketing) author
Gadaska, Angela, author
Knowles, Molly, author
Haber, Susan, author
Ingber, Melvin J., author
Grouverman, Valentina, author
- Publication:
- Washington, D.C. : U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Behavioral Health, Disability, and Aging Policy, September 2021
- Subject(s):
- Delivery of Health Care, Integrated
Dual MEDICAID MEDICARE Eligibility
Outcome Assessment, Health Care
United States
United States. Department of Health and Human Services.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
- Subject(s):
- Drug Approval
Drugs, Generic
Investigational New Drug Application
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 2019
- Subject(s):
- Drug Compounding -- standards
5-Hydroxytryptophan -- therapeutic use
Phenylketonurias -- drug therapy
Guideline Adherence
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 Tobacco Products, November 2019
- Subject(s):
- Electronic Nicotine Delivery Systems -- standards
Nicotine -- adverse effects
Tobacco Products -- adverse effects
Child
Consumer Product Safety
Equipment Failure
Product Packaging
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, September 2017
- Subject(s):
- Product Labeling -- standards
Product Packaging -- standards
Tobacco Products -- standards
Guideline Adherence
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 2020
- Subject(s):
- Biological Availability
Therapeutic Equivalency
Biopharmaceutics
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, January 2018
- Subject(s):
- Drug Compounding -- 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, January 2018
- Subject(s):
- Drug Compounding -- 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 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.
- Author(s):
- Dhopeshwarkar, Rina, author
Heaney-Huls, Krysta, author
Hovey, Lauren, author
Leaphart, Desirae, author
Dullabh, Prashila, author
- Publication:
- Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, September 22, 2021
- Subject(s):
- Data Collection
Developmental Disabilities
Intellectual Disability
Patient-Centered Care
Research Design
United States
United States. Department of Health and Human Services.
- 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 Biologics Evaluation and Research, December 2019
- Subject(s):
- Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
Plasma -- microbiology
Product Packaging
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 2019
- Subject(s):
- Clinical Trials as Topic -- ethics
Adolescent
Neoplasms -- drug therapy
Adult
Medical Oncology -- ethics
Patient Safety
Patient Selection
Pharmacokinetics
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 2019
- Subject(s):
- Biosimilar Pharmaceuticals -- standards
Drug Substitution
Proteins -- therapeutic use
Biological Products
Clinical Trials as Topic
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, 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, February 2021
- Subject(s):
- Drug Contamination -- prevention & control
Nitrosamines
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 14, 2020
- Subject(s):
- Equipment Design
Equipment Safety
Urinary Catheterization
Urinary Catheters -- standards
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 1, 2019
- Subject(s):
- Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
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 14, 2020
- Subject(s):
- Electrodes
Equipment Design
Equipment Safety
Electrocardiography
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 2020
- Subject(s):
- Cytomegalovirus Infections -- drug therapy
Cytomegalovirus Infections -- prevention & control
Organ Transplantation
Stem Cell Transplantation
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, March 2017
- Subject(s):
- Data Collection
Eligibility Determination
Health Insurance Exchanges
Cost Sharing
Federal Government
Government Regulation
Humans
United States
United States. Department of Health and Human Services.
United States.
Centers for Medicare & Medicaid Services (U.S.)
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, October 30, 2017
- Subject(s):
- Classification
Device Approval -- standards
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, October 25, 2017
- Subject(s):
- Device Approval -- standards
Equipment Design -- standards
Equipment Safety -- standards
Product Labeling -- 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 Devices and Radiological Health, October 25, 2017
- Subject(s):
- Device Approval -- standards
Software -- standards
Computer Security
Equipment Design -- standards
Equipment Safety -- standards
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, 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.