Concepedia

Labeling Approval

Labeling Approval is a regulatory authorization that specifies the permitted content and format of product information for a pharmaceutical, distinguishing it as a formal, legally binding component of market authorization that governs the communication of efficacy, safety, and usage data to healthcare professionals and patients.

16

Publications

435

Citations

42

Authors

30

Institutions

Publications per year

2017–2026

6

Parents

Publications

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

, , +9

Use of approved drugs for unlabeled indications.

Stratton Wt · PubMed · 1982 · 66 citations

, , +6

Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014)

Ari Gnanasakthy, Carla DeMuro, Marci Clark et al. · Journal of Clinical Oncology · 2016 · 56 citations

, , +17

Japanese Regulatory System for Approval of Off-Label Drug Use: Evaluation of Safety and Effectiveness in Literature-Based Applications

Rumiko Shimazawa, Masayuki Ikeda · Clinical Therapeutics · 2012 · 27 citations

, , +16

The Use of Food and Drug Administration Approved Medications for Unlabeled (Off-Label) Uses

Abel Torres · Archives of Dermatology · 1994 · 24 citations

, , +15

1–5 of 16

Authors

42

  1. AG
    Ari Gnanasakthy

    RTI Health Solutions, United States

    2 publications · 134 citations

    2

    h-index

  2. MC
    Marci Clark

    RTI Health Solutions, United States

    2 publications · 134 citations

    2

    h-index

  3. CD
    Carla DeMuro

    RTI Health Solutions, United States

    2 publications · 134 citations

    2

    h-index

  4. RD
    Riyan Deria

    Wake Forest University, United States

    1 publications · 20 citations

    1

    h-index

  5. RM
    Richard Moscicki

    Massachusetts General Hospital, United States

    1 publications · 19 citations

    1

    h-index

1–5 of 42

Institutions

30

  1. United States Food and Drug Administration

    Silver Spring, United States

    2 h-index

    3 publications

    59 citations

  2. RTI Health Solutions

    Durham, United States

    2 h-index

    11 publications

    726 citations

  3. University of Washington

    Seattle, United States

    1 h-index

    2 publications

    44 citations

  4. Loma Linda University Health Care

    Loma Linda, United States

    1 h-index

    1 publications

    24 citations

  5. Nagasaki University

    Nagasaki, Japan

    1 h-index

    2 publications

    54 citations

  6. University of Pennsylvania

    Philadelphia, United States

    1 h-index

    2 publications

    42 citations

  7. University of Iowa

    Iowa City, United States

    1 h-index

    1 publications

    13 citations

  8. Wake Forest University

    Winston-Salem, United States

    1 h-index

    2 publications

    40 citations

1–8 of 30

Venues

  1. New England Journal of Medicine

    NEJM · 2 publications · 35 citations

    2

    h-index

  2. Therapeutic Innovation & Regulatory Science

    TIRS · 1 publications · 19 citations

    1

    h-index

  3. Obstetrics and Gynecology

    1 publications · 15 citations

    1

    h-index

  4. Journal of Nuclear Medicine

    1 publications · 13 citations

    1

    h-index

  5. PubMed

    Repository · 1 publications · 66 citations

    1

    h-index

1–5