Search
Search Results
- 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
Drugs, Investigational -- therapeutic use
Herpes Labialis -- drug therapy
Herpes Labialis -- prevention & control
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 2017
- Subject(s):
- Automobile Driving
Driving Under the Influence
Drug Evaluation -- standards
Psychotropic Drugs -- adverse effects
Evaluation Studies as Topic
Reaction Time -- drug 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, December 2017
- Subject(s):
- Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Tissue Transplantation -- standards
Transplantation, Autologous
Transplantation, Homologous
Transplants -- standards
Prostheses and Implants -- standards
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, November 2017
- Subject(s):
- Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Tissue Transplantation
Transplantation, Autologous
Transplantation, Homologous
Transplants -- standards
Prostheses and Implants -- standards
Surgical Procedures, Operative
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, November 17, 2017
- Subject(s):
- Equipment and Supplies -- standards
Equipment Reuse -- standards
Product Labeling -- standards
Device Approval -- 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 2017
- Subject(s):
- Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
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, November 28, 2017
- Subject(s):
- Equipment Safety -- standards
Product Labeling -- standards
Radiation Dosage
Radiation Exposure -- adverse effects
Radiation Exposure -- standards
Radiography -- adverse effects
Radiography -- instrumentation
Adolescent
Child
Child, Preschool
Contraindications
Fluoroscopy -- adverse effects
Fluoroscopy -- instrumentation
Infant
Infant, Newborn
Radiation, Ionizing
Tomography Scanners, X-Ray Computed -- standards
Tomography, X-Ray Computed -- adverse effects
Young Adult
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 2017
- Subject(s):
- Blood Donors
Donor Selection -- standards
Hepacivirus
Hepatitis C -- blood
HIV Infections -- blood
HIV-1
RNA, Viral -- blood
Blood -- virology
Blood Transfusion
Disease Transmission, Infectious -- prevention & control
Nucleic Acid Amplification Techniques
Polymerase Chain Reaction
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 5, 2017
- Subject(s):
- Device Approval
Equipment and Supplies
Insurance Coverage
Medicare -- economics
Therapies, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Centers for Medicare & Medicaid Services (U.S.)
- 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 Biologics Evaluation and Research, December 2017
- Subject(s):
- Blood Donors
Chagas Disease -- blood
Chagas Disease -- transmission
Disease Transmission, Infectious -- prevention & control
Donor Selection
Serologic Tests
Trypanosoma cruzi
Chagas Disease -- prevention & control
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, 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.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
- Subject(s):
- Advertising as Topic -- standards
Prescription Drugs -- standards
Product Labeling -- standards
Mass Media
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, December 2017
- Subject(s):
- Antibacterial Agents
Antifungal Agents
Drug Labeling -- standards
Investigational New Drug Application
Microbial Sensitivity 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, December 2017
- Subject(s):
- Biological Availability
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Therapeutic Equivalency
Administration, Oral
Biopharmaceutics -- classification
Drugs, Investigational -- administration & dosage
Excipients
Permeability
Prodrugs
Solubility
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, 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 Biologics Evaluation and Research, January 16, 2018
- Subject(s):
- Equipment and Supplies -- classification
Product Labeling -- standards
Product Packaging -- 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, 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 Drug Evaluation and Research, January 2018
- Subject(s):
- Biological Products
Drug Approval
Drug Packaging
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, 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:
- Washington, D.C. : U.S. Government Accountability Office, May 2017
- Subject(s):
- Dietary Supplements
Drug and Narcotic Control
Government Regulation
Marketing of Health Services
Memory -- drug effects
Memory Disorders -- drug therapy
Advertising as Topic
Commerce
Internet
Humans
United States
United States. Federal Trade Commission.
United States. Food and Drug Administration.
- Publication:
- Washington, D.C. : U.S. Government Accountability Office, May 2017
- Subject(s):
- Drugs, Generic -- economics
Drugs, Investigational -- economics
Investigational New Drug Application -- economics
Drug Approval -- economics
Humans
United States
United States. Food and Drug Administration.
- Publication:
- Washington, D.C. : U.S. Government Accountability Office, July 2017
- Subject(s):
- Adverse Drug Reaction Reporting Systems
Drugs, Investigational -- adverse effects
Drugs, Investigational -- therapeutic use
Drug Approval
Health Services Accessibility
Humans
United States
United States. Food and Drug Administration.
- Publication:
- Washington, D.C. : U.S. Government Accountability Office, October 3, 2017
- Subject(s):
- Drug Approval -- statistics & numerical data
Drugs, Investigational -- therapeutic use
Health Services Accessibility
Patient Safety
Investigational New Drug Application
Humans
United States
United States. Food and Drug Administration.
- Publication:
- Washington, DC : United States Government Accountability Office, September 2017
- Subject(s):
- Anti-Bacterial Agents -- adverse effects
Commerce -- standards
Drug Residues -- standards
Fishes
Food Contamination -- prevention & control
Food Safety
Food Supply -- standards
Hazard Analysis and Critical Control Points
Seafood
Aquaculture -- standards
Catfishes
Food Safety -- methods
Government Regulation
Public Health
Humans
Asia
Canada
United States
United States. Department of Agriculture.
United States. Food and Drug Administration.
- Publication:
- Washington, DC : United States Government Accountability Office, November 1, 2017
- Subject(s):
- Government Agencies
Interinstitutional Relations
Radiation Effects
Radiation, Ionizing
Research
Radiation Dosage
Humans
United States
United States. Department of Energy.
United States. Environmental Protection Agency.
United States. Food and Drug Administration.
U.S. Nuclear Regulatory Commission.
- Publication:
- Washington, DC : United States Government Accountability Office, November 2017
- Subject(s):
- Drug Approval
Nonprescription Drugs
Sunscreening Agents
Consumer Product Safety
Humans
United States
United States. Food and Drug Administration.
- Publication:
- Washington, DC : United States Government Accountability Office, November 2017
- Subject(s):
- Commerce
Food Contamination
Food Safety
Fruit
Vegetables
Water Pollution
Water Supply
Humans
United States
United States. Food and Drug Administration.
- Publication:
- Washington, DC : United States Government Accountability Office, December 2017
- Subject(s):
- Device Approval -- standards
Equipment Safety
Federal Government
Forecasting
Government Regulation
Inservice Training
Humans
United States
United States. Food and Drug Administration.
- Publication:
- Washington, DC : United States Government Accountability Office, December 2017
- Subject(s):
- Drug Approval
Drugs, Generic
Therapeutic Equivalency
Chemistry, Pharmaceutical
Doxorubicin
Drug Development
Enoxaparin
Glatiramer Acetate
Gluconates
Propofol
Humans
United States
United States. Food and Drug Administration.
- Publication:
- [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
- Subject(s):
- Breast Neoplasms
Clinical Trials as Topic
Neoadjuvant Therapy
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, Office of Product Evaluation and Quality, July 2020
- Subject(s):
- Culture Media
Specimen Handling
Transportation
Virus Diseases
COVID-19
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 2020
- Subject(s):
- Biological Products
Tissues
Cell- and Tissue-Based Therapy
Tissue Transplantation
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 : 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
Heart Failure
Liver Failure
Neoplasms
Renal Insufficiency
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):
- Legislation, Drug
Legislation, Food
Marketing -- legislation & jurisprudence
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, April 2020
- Subject(s):
- Adolescent Behavior
Adolescent Health
Electronic Nicotine Delivery Systems
Vaping -- prevention & control
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- [College Park, MD] : Center for Food Safety and Applied Nutrition, April 2020
- Subject(s):
- Accreditation -- methods
Certification -- methods
Food Safety
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, Office of Pharmaceutical Quality and Office of Compliance, April 2020
- Subject(s):
- Drug Packaging -- methods
Propofol -- supply & distribution
COVID-19
Drug Labeling
Pharmacies
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, August 2020
- Subject(s):
- Blood Donors
Blood Transfusion
Creutzfeldt-Jakob Syndrome -- prevention & control
Creutzfeldt-Jakob Syndrome -- transmission
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, August 2020
- Subject(s):
- Blood Donors
Blood Transfusion
HIV
HIV Infections -- prevention & control
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
Malaria -- prevention & control
Malaria -- transmission
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, Office of Compliance May 21, 2020
- Subject(s):
- Drug Compounding -- methods
Hospitalization
Outsourced Services
Pharmacies
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, May 21, 2020
- Subject(s):
- Drug Compounding -- methods
Hospitalization
Outsourced Services
COVID-19
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, Office of Product Evaluation and Quality, April 2020
- Subject(s):
- Thermometers -- supply & distribution
COVID-19
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, Office of Product Evaluation and Quality April 2020
- Subject(s):
- Cardiopulmonary Bypass -- instrumentation
Extracorporeal Membrane Oxygenation -- instrumentation
COVID-19 -- therapy
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.