Subjects: Drug Approval and United States. Department of Health and Human Services. - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Approval ✖ Subjects United States. Department of Health and Human Services. ✖ Publication Year 2017 to 2019 ✖

31. 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.

32. Risk evaluation and mitigation strategies: modifications and revisions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
Subject(s):: Risk Evaluation and Mitigation -- standards
Drug Approval
Drug Labeling
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

33. 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.

34. 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.

35. 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.