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- 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 Biologics Evaluation and Research, September 20, 2019
- Subject(s):
- Drug Approval
Therapeutic Equivalency
Safety
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, February 5, 2019
- Subject(s):
- Device Approval
Equipment 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, June 14, 2019
- Subject(s):
- Device Approval
Equipment and Supplies -- classification
Gastroenterology -- instrumentation
Gynecology
Obstetrics -- instrumentation
Otolaryngology -- instrumentation
Physical and Rehabilitation Medicine -- instrumentation
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 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.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, September 13, 2019
- Subject(s):
- Device Approval -- standards
Checklist
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 2019
- Subject(s):
- Buprenorphine -- therapeutic use
Drug Development
Opioid-Related Disorders -- drug therapy
Buprenorphine -- administration & dosage
Clinical Trials as Topic
Delayed-Action Preparations
Narcotic Antagonists
Opiate Substitution Treatment
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, February 2019
- Subject(s):
- Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
Biological Products -- classification
Cell- and Tissue-Based Therapy -- classification
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, 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, March 2019
- Subject(s):
- Drug Evaluation, Preclinical -- standards
Hematologic Diseases -- drug therapy
Animals
Carcinogenicity Tests
Cytotoxicity Tests, Immunologic
Drug Therapy, Combination
Drug-Related Side Effects and Adverse Reactions
Immunologic Tests
Mutagenicity Tests
Pediatrics
Pharmacokinetics
Photochemistry
Safety
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
