Labeling Decisions is a regulatory science construct that specifies the process of determining the content, format, and placement of risk and benefit information in product labeling based on the evaluation of clinical and pharmacological evidence within the context of benefit-risk assessment.
55
Publications
3.8K
Citations
197
Authors
94
Institutions
Publications per year
2017–2026
12
Parents
Publications
55
1–5 of 55
Authors
197
- LJLawrence J. Lesko
Center for Drug Evaluation and Research, United States
4 publications · 305 citations
4
h-index
- AG
3
h-index
- VAVenkatesh Atul Bhattaram
Center for Drug Evaluation and Research, United States
2 publications · 266 citations
2
h-index
- MC
2
h-index
- JM
2
h-index
1–5 of 197
Institutions
94
Center for Drug Evaluation and Research
Silver Spring, United States
5 h-index
24 publications
2.1K citations
United States Food and Drug Administration
Silver Spring, United States
5 h-index
25 publications
2.6K citations
Pfizer (United States)
New York, United States
2 h-index
2 publications
36 citations
Michigan State University
East Lansing, United States
2 h-index
4 publications
58 citations
University of Florida
Gainesville, United States
2 h-index
3 publications
49 citations
RTI Health Solutions
Durham, United States
2 h-index
11 publications
726 citations
Duke University
Durham, United States
2 h-index
2 publications
87 citations
Novartis (Switzerland)
Basel, Switzerland
2 h-index
3 publications
104 citations
1–8 of 94
Venues
- PubMed
Repository · 3 publications · 93 citations
3
h-index
- Journal of Personality and Social Psychology
2 publications · 1.3K citations
2
h-index
- Journal of Risk Research
2 publications · 35 citations
2
h-index
- JAMA
2 publications · 29 citations
2
h-index
- New England Journal of Medicine
NEJM · 2 publications · 103 citations
2
h-index
1–5