NLM Digital Collections

Search

Start Over Subjects Drug Approval ✖Remove constraint Subjects: Drug Approval

82. Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):
Administration, Topical
Drug Approval
Nonprescription Drugs
Absorption, Physiological
Clinical Trials as Topic
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

84. Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Chromatography -- standards
Drug Approval
Quality Control
Reference Standards
Calibration
Chemistry Techniques, Analytical
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

85. 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.

86. Considerations for the development of dried plasma products intended for transfusion

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, December 2019
Subject(s):
Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
Plasma -- microbiology
Product Packaging
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

88. One percent of drugs with Medicaid reimbursement were not FDA-approved

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2019
Subject(s):
Drug Approval
Insurance, Health, Reimbursement -- economics
Insurance, Health, Reimbursement -- statistics & numerical data
Medicaid -- economics
Medicaid -- statistics & numerical data
Economics, Pharmaceutical
Fraud -- prevention & control
Prescription Drugs -- economics
Humans
United States
United States. Food and Drug Administration.