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Search Results
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
- Subject(s):
- Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
- Subject(s):
- Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- College Park, MD : Center for Food Safety and Applied Nutrition, June 2023
- Subject(s):
- Arsenic
Food Safety
Food Supply
Government Regulation
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
- Subject(s):
- Biological Products
Drug Development -- legislation & jurisprudence
Government Regulation
Leukemia, Myeloid, Acute -- drug therapy
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
- Subject(s):
- Biological Products
Drug Industry
Government Regulation
Pharmaceutical Preparations
Randomized Controlled Trials as Topic
United States
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
- Subject(s):
- Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
- Subject(s):
- Biomedical Technology -- standards
Drug Industry -- standards
Inventions
Quality Assurance, Health Care
Quality Improvement
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- 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, June 2023
- Subject(s):
- Biological Products -- standards
Blood Platelets
Government Regulation
Platelet Transfusion
Refrigeration
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
- Subject(s):
- Forms as Topic
Government Regulation
Product Surveillance, Postmarketing
United States
United States.
United States.
- 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:
- Edinburgh, Scotland : SIGN, 2000
- Subject(s):
- Antibiotic Prophylaxis
Surgical Wound Infection -- prevention & control
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2023
- Subject(s):
- Government Regulation
Medical Device Legislation
Microbial Sensitivity Tests -- standards
Product Labeling
United States
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 2023
- Subject(s):
- Bioengineering
Device Approval
Drug Development
Drug Industry
Ergonomics
Government Regulation
United States
- 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 : Center for Drug Evaluation and Research, June 2022
- Subject(s):
- Administration, Oral
Drug Approval
Drugs, Investigational
Food-Drug Interactions
Government Regulation
United States
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.
- 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, 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:
- College Park, MD : Center for Food Safety and Applied Nutrition, December 2022
- Subject(s):
- Advisory Committees
Consumer Product Safety
Government Regulation
Legislation, Drug
United States
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:
- Edinburgh, Scotland : Scottish Intercollegiate Guidelines Network (SIGN), March 2013
- Subject(s):
- Brain Injuries -- rehabilitation
Scotland
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2023
- Subject(s):
- Data Collection
Device Approval
Government Regulation
Medical Device Legislation
United States
United States.
United States.
- Publication:
- Edinburgh, Scotland : Scottish Intercollegiate Guidelines Network (SIGN), October 2014
- Subject(s):
- Asthma -- therapy
United Kingdom
Scotland
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
- Subject(s):
- Drug Industry
Government Regulation
Quality Control
Reference Standards
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
- Subject(s):
- Clinical Trials as Topic
Government Regulation
Neoplasms -- drug therapy
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, January 2023
- Subject(s):
- Cannabis
Drug Development
Government Regulation
Medical Marijuana
United States
United States. Food and Drug Administration
- Publication:
- Edinburgh, Scotland : Scottish Intercollegiate Guidelines Network (SIGN), May 2014
- Subject(s):
- Disease Progression
Patient Care Planning
Sepsis -- therapy
Scotland
- 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 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, June 2023
- Subject(s):
- Drug Development
Drug Industry
Government Regulation
Nasal Polyps -- drug therapy
Sinusitis -- drug therapy
United States
- 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 : 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 Devices and Radiological Health, September 28, 2022
- Subject(s):
- Clinical Decision-Making
Decision Making, Computer-Assisted
Government Regulation
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
- Subject(s):
- Contraceptives, Oral
Drug Evaluation
Drug Industry
Drug Interactions
Government Regulation
United States
- 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, October 2022
- Subject(s):
- Biological Products
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
- Subject(s):
- Drug Approval
Drugs, Generic
Government Regulation
Therapeutic Equivalency
United States
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, 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 Drug Evaluation and Research, November 2022
- Subject(s):
- Anti-Bacterial Agents
beta-Lactams
Drug Compounding
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2023
- Subject(s):
- Administration, Oral
Drug Compounding -- methods
Drug Compounding -- standards
Drug Industry
Government Regulation
Ibuprofen
Legislation, Drug
Suspensions
United States
United States. Food and Drug Administration
United States.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, September 28, 2022
- Subject(s):
- Diagnosis, Computer-Assisted
Device Approval
Government Regulation
Radiographic Image Interpretation, Computer-Assisted
United States
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 Drug Evaluation and Research, September 2023
- Subject(s):
- Clinical Trials as Topic
Disasters
Emergencies
Government Regulation
Public Health
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
- Subject(s):
- Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.
- 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 Devices and Radiological Health, June 14, 2023
- Subject(s):
- Device Approval
Government Regulation
Software -- legislation & jurisprudence
Software -- standards
Software Design
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
- Subject(s):
- Correspondence as Topic
Drug Approval
Drug Industry
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
- Subject(s):
- Antineoplastic Combined Chemotherapy Protocols
Drug Labeling -- legislation & jurisprudence
Government Regulation
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 27, 2023
- Subject(s):
- Computer Security
Device Approval
Equipment Safety
Government Regulation
Medical Device Legislation
United States
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, March 30, 2023
- Subject(s):
- Computer Security -- legislation & jurisprudence
Device Approval
Equipment Safety
Government Regulation
United States
United States.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
- Subject(s):
- Drug Industry
Government Regulation
Guidelines as Topic
Information Dissemination
Legislation, Drug
Prescription Drugs -- standards
United States
- 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:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2023
- Subject(s):
- Drug Industry
Legislation, Drug
Drug Packaging
Drug and Narcotic Control
Government Regulation
United States
- Publication:
- Edinburgh, Scotland : Scottish Intercollegiate Guidelines Network (SIGN), March 2014
- Subject(s):
- Dental Care for Children
Dental Caries -- prevention & control
Dental Devices, Home Care
Scotland
- 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 29, 2017
- Subject(s):
- Device Approval -- standards
Communication
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Edinburgh, Scotland : Scottish Intercollegiate Guidelines Network (SIGN), August 2016
- Subject(s):
- Colorectal Neoplasms -- diagnosis
Colorectal Neoplasms -- prevention & control
Disease Management
Scotland
- Publication:
- Edinburgh, Scotland : Scottish Intercollegiate Guidelines Network (SIGN), 2018
- Subject(s):
- Epilepsy -- diagnosis
Epilepsy -- therapy
Scotland
- Publication:
- Edinburgh, Scotland : Scottish Intercollegiate Guidelines Network (SIGN), October 2010
- Subject(s):
- Arthritis, Psoriatic -- therapy
Psoriasis -- therapy
Arthritis, Psoriatic -- diagnosis
Disease Management
Psoriasis -- diagnosis
Acitretin -- therapeutic use
Scotland
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
- Subject(s):
- Data Display -- standards
Image Processing, Computer-Assisted -- standards
Radiology Information Systems -- standards
Device Approval -- standards
Product Labeling -- standards
Software -- standards
Technology, Radiologic -- 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 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, 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 Drug Evaluation and Research, June 2023
- Subject(s):
- Cytokines
Drug Industry
Drug Interactions
Government Regulation
United States
- 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, 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, August 2022
- Subject(s):
- Arrhythmias, Cardiac
Clinical Trials as Topic
Electrocardiography
Government Regulation
United States
- 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, 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, 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, December 2022
- Subject(s):
- Clinical Trials as Topic
Data Collection
Government Regulation
Patient Safety
United States
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:
- Edinburgh, Scotland : SIGN, 2000
- Subject(s):
- Craniocerebral Trauma -- diagnosis
Craniocerebral Trauma -- therapy
Scotland
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 22, 2022
- Subject(s):
- Device Approval
Government Regulation
United States
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 : 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] : Center for Devices and Radiological Health, March 13, 2023
- Subject(s):
- COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
Personal Protective Equipment
United States
United States. Food and Drug Administration
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, March 13, 2023
- Subject(s):
- COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
N95 Respirators -- standards
Personal Protective Equipment
Respiratory Protective Devices -- standards
United States
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, August 2023
- Subject(s):
- Drug Industry
Drug and Narcotic Control
Drug Packaging
Government Regulation
Security Measures
United States
United States.
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 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, 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, 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 Drug Evaluation and Research, March 2023
- Subject(s):
- Drug Industry
Drug Interactions
Gastrointestinal Agents
Government Regulation
Hydrogen-Ion Concentration
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
- Subject(s):
- Government Regulation
Legislation, Drug
Naloxone -- supply & distribution
Opioid Epidemic -- prevention & control
United States
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 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 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 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, December 2022
- Subject(s):
- Drug Approval
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration