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- 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 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, 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 Biologics Evaluation and Research, October 2019
- Subject(s):
- Blood -- virology
Blood Banks -- standards
Blood Donors
Hepatitis C -- blood
Hepatitis C -- transmission
Donor Selection
Hepatitis C Antibodies -- blood
Nucleic Acid Amplification Techniques
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 2019
- Subject(s):
- Drug Evaluation, Preclinical -- standards
Enzyme Replacement Therapy -- standards
Models, Animal
Research Design
Safety
Toxicity Tests -- standards
Animals
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, Oncology Center of Excellence, October 2019
- Subject(s):
- Clinical Trials as Topic
Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
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, October 2019
- Subject(s):
- Drug Approval -- economics
Drug Approval -- legislation & jurisprudence
Investigational New Drug Application -- legislation & jurisprudence
Diffusion of Innovation
Economics, Pharmaceutical
Orphan Drug Production -- economics
Public Health
Small Business
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, November 14, 2019
- Subject(s):
- Commerce -- legislation & jurisprudence
Equipment and Supplies -- standards
Device Approval -- legislation & jurisprudence
Equipment Safety
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 2019
- Subject(s):
- Clinical Trials as Topic
Drug Development -- standards
Smallpox -- drug therapy
Smallpox -- prevention & control
Antiviral Agents -- pharmacology
Antiviral Agents -- therapeutic use
Drug Evaluation, Preclinical
Emergencies
Investigational New Drug Application
Models, Animal
Orthopoxvirus
Public Health
Research Design
Safety
Toxicity Tests
Variola virus
Animals
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, 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.