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Start Over Subjects Clinical Trials as Topic ✖Remove constraint Subjects: Clinical Trials as Topic Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services.

41. Delayed graft function in kidney transplantation: developing drugs for prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
Subject(s):
Delayed Graft Function -- drug therapy
Drug Development -- standards
Kidney Transplantation
Clinical Trials as Topic
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

42. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 11, 2019
Subject(s):
Clinical Trials as Topic
Device Approval
Data Collection
Ethics Committees, Research
Informed Consent
Single-Case Studies as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

45. Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Anticonvulsants -- therapeutic use
Clinical Trials as Topic
Drug Development -- standards
Seizures -- drug therapy
Adolescent
Anticonvulsants -- pharmacology
Child
Child, Preschool
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

46. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

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.

47. Smallpox (variola virus) infection: developing drugs for treatment or prevention

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.