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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
- Subject(s):
- Biomarkers
Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Hematologic Neoplasms -- drug therapy
Investigational New Drug Application
Neoplasm, Residual
Endpoint Determination
Leukemia, Lymphocytic, Chronic, B-Cell -- drug therapy
Leukemia, Myelogenous, Chronic, BCR-ABL Positive -- drug therapy
Leukemia, Myeloid, Acute -- drug therapy
Leukemia, Promyelocytic, Acute -- drug therapy
Multiple Myeloma -- drug therapy
Patient Selection
Precursor Cell Lymphoblastic Leukemia-Lymphoma -- drug therapy
Prognosis
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 2019
- Subject(s):
- Drug Evaluation -- legislation & jurisprudence
Risk Evaluation and Mitigation -- legislation & jurisprudence
Cost of Illness
Drug-Related Side Effects and Adverse Reactions
Health Services Accessibility
Prescription Drugs -- adverse effects
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 2019
- Subject(s):
- Anthrax -- drug therapy
Civil Defense
Doxycycline -- supply & distribution
Doxycycline -- therapeutic use
Post-Exposure Prophylaxis
Strategic Stockpile
Biological Availability
Drug Stability
Drug Storage
Legislation, Drug
Biological Availability
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, 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, 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, April 26, 2019
- Subject(s):
- Equipment and Supplies -- standards
Product Labeling -- standards
Equipment Reuse
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 Devices and Radiological Health, May 7, 2019
- Subject(s):
- Congresses as Topic -- 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 Devices and Radiological Health, May 8, 2019
- Subject(s):
- Device Approval -- standards
Evaluation Studies as Topic
Organ Preservation -- instrumentation
Organ Preservation -- standards
Perfusion -- instrumentation
Reperfusion -- instrumentation
Animals
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):
- Device Approval -- standards
Electrical Equipment and Supplies -- classification
Electrical Equipment and Supplies -- standards
Radiography -- classification
Radiography -- instrumentation
Equipment Safety
Guideline Adherence
Tomography Scanners, X-Ray Computed -- 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, May 8, 2019
- Subject(s):
- Fluoroscopy -- standards
Radiation Exposure -- standards
Equipment Safety
Fluoroscopy -- instrumentation
Radiation Exposure -- prevention & control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
