Concepedia

Labeling Review

Labeling Review is a regulatory evaluation process, distinguished from other pre-approval assessments by its specific focus on analyzing and approving the content, accuracy, and compliance of drug product labeling to ensure appropriate medical use and patient safety.

34

Publications

1.8K

Citations

124

Authors

53

Institutions

Publications per year

2017–2026

13

Parents

Children

Publications

34

Labeling Accuracy of Cannabidiol Extracts Sold Online

Marcel O. Bonn‐Miller, Mallory Loflin, Brian F. Thomas et al. · JAMA · 2017 · 530 citations · Full text

, , +11

Participatory organic certification in Mexico: an alternative approach to maintaining the integrity of the organic label

Erin Nelson, Laura Gómez Tovar, Rita Schwentesius Rindermann et al. · Agriculture and Human Values · 2009 · 129 citations

, , +12

Audit of manufactured products: Use of allergen advisory labels and identification of labeling ambiguities

Mariah M. Pieretti, Danna Chung, Robert Pacenza et al. · Journal of Allergy and Clinical Immunology · 2009 · 126 citations · Full text

, , +14

Uses of Drugs Not Described in the Package Insert (Off-Label Uses)

PEDIATRICS · 2002 · 96 citations

, , +16

Assessment of PRO Label Claims Granted by the FDA as Compared to the EMA (2006–2010)

Carla DeMuro, Marci Clark, Lynda Doward et al. · Value in Health · 2013 · 78 citations · Full text

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1–5 of 34

Authors

124

  1. CD
    Carla DeMuro

    RTI Health Solutions, United States

    2 publications · 134 citations

    2

    h-index

  2. AG
    Ari Gnanasakthy

    RTI Health Solutions, United States

    2 publications · 134 citations

    2

    h-index

  3. MC
    Marci Clark

    RTI Health Solutions, United States

    2 publications · 134 citations

    2

    h-index

  4. IB
    Ilynn Bulatao

    Mayo Clinic in Florida, United States

    1 publications · 27 citations

    1

    h-index

  5. JC
    Julie C. Sung

    Icahn School of Medicine at Mount Sinai, United States

    1 publications · 13 citations

    1

    h-index

1–5 of 124

Institutions

53

  1. Center for Drug Evaluation and Research

    Silver Spring, United States

    5 h-index

    17 publications

    369 citations

  2. United States Food and Drug Administration

    Silver Spring, United States

    4 h-index

    14 publications

    314 citations

  3. Icahn School of Medicine at Mount Sinai

    New York, United States

    2 h-index

    5 publications

    404 citations

  4. RTI Health Solutions

    Durham, United States

    2 h-index

    11 publications

    726 citations

  5. Research Triangle Park Foundation

    Durham, United States

    1 h-index

    5 publications

    390 citations

  6. Palo Alto University

    Palo Alto, United States

    1 h-index

    1 publications

    530 citations

  7. Mount Sinai Hospital

    New York, United States

    1 h-index

    1 publications

    126 citations

  8. Nantes Université

    Nantes, France

    1 h-index

    1 publications

    41 citations

1–8 of 53

Venues

  1. PubMed

    Repository · 3 publications · 81 citations

    3

    h-index

  2. JAMA

    3 publications · 592 citations

    3

    h-index

  3. Drug Safety

    2 publications · 39 citations

    2

    h-index

  4. Therapeutic Innovation & Regulatory Science

    TIRS · 2 publications · 30 citations

    2

    h-index

  5. Value in Health

    2 publications · 97 citations

    2

    h-index

1–5