Concepedia

Product Labeling Changes

Product Labeling Changes is a regulatory risk minimization measure that consists of modifications to the approved informational content accompanying a pharmaceutical product, distinguished by its intent to enhance safe and effective use based on emerging postmarketing safety or efficacy data.

24

Publications

1.2K

Citations

89

Authors

56

Institutions

Publications per year

2017–2026

9

Variants

Labeling Changes

Parents

Publications

24

The Effects of Ingredient Branding Strategies on Host Brand Extendibility

Kalpesh Kaushik Desai, Kevin Lane Keller · Journal of Marketing · 2002 · 394 citations

, , +15

Peer-Reviewed Publication of Clinical Trials Completed for Pediatric Exclusivity

Daniel K. Benjamin, Philip Brian Smith, M. Dianne Murphy et al. · JAMA · 2006 · 144 citations · Full text

, , +13

Investigations by<sup>13</sup>C NMR Spectroscopy of Ethene-Initiated Catalytic CO Hydrogenation

Michael L. Turner, Nyoman Marsih, Brian E. Mann et al. · Journal of the American Chemical Society · 2002 · 102 citations

, , +16

Psoriasis disease severity measures: comparing efficacy of treatments for severe psoriasis

Steven M. Weisman, C. Pollack, R. Gottschalk · Journal of Dermatological Treatment · 2003 · 80 citations

, , +16

Regulatory initiatives to reduce sugar-sweetened beverages (SSBs) in Latin America

Paola Bergallo, Valentina Castagnari, Alicia Fernández et al. · PLoS ONE · 2018 · 73 citations · Full text

, , +17

1–5 of 24

Authors

89

  1. PB
    Philip Brian Smith

    Food and Drug Administration, Thailand

    1 publications · 144 citations

    1

    h-index

  2. KL
    Karen L. Hagerty

    American Society of Clinical Oncology, United States

    1 publications · 10 citations

    1

    h-index

  3. ML
    Michael L. Turner

    University of Manchester, United Kingdom

    1 publications · 102 citations

    1

    h-index

  4. PY
    Pooja Yesantharao

    Johns Hopkins University, United States

    1 publications · 13 citations

    1

    h-index

  5. SE
    Steven E. Kern

    University of Utah, United States

    1 publications · 26 citations

    1

    h-index

1–5 of 89

Institutions

56

  1. United States Food and Drug Administration

    Silver Spring, United States

    3 h-index

    9 publications

    344 citations

  2. Center for Drug Evaluation and Research

    Silver Spring, United States

    2 h-index

    8 publications

    200 citations

  3. Kaiser Permanente Washington Health Research Institute

    Seattle, United States

    1 h-index

    1 publications

    22 citations

  4. Macau University of Science and Technology

    Macao, Macao

    1 h-index

    1 publications

    15 citations

  5. Unity Health System

    Rochester, United States

    1 h-index

    4 publications

    64 citations

  6. Food and Drug Administration

    Nonthaburi, Thailand

    1 h-index

    1 publications

    144 citations

  7. University of Washington

    Seattle, United States

    1 h-index

    2 publications

    44 citations

  8. Icahn School of Medicine at Mount Sinai

    New York, United States

    1 h-index

    2 publications

    26 citations

1–8 of 56

Venues

  1. New England Journal of Medicine

    NEJM · 2 publications · 68 citations

    2

    h-index

  2. Pharmaceutics

    1 publications · 11 citations

    1

    h-index

  3. PubMed

    Repository · 1 publications · 13 citations

    1

    h-index

  4. Food Quality and Preference

    1 publications · 20 citations

    1

    h-index

  5. PLoS ONE

    1 publications · 73 citations

    1

    h-index

1–5