Concepedia

Post-marketing Commitments

Post-Marketing Commitments is a regulatory obligation imposed on pharmaceutical marketing authorization holders to conduct specified studies or activities after product approval, distinguishing it from pre-approval requirements by ensuring ongoing evaluation of safety, efficacy, or quality under real-world conditions.

15

Publications

376

Citations

79

Authors

57

Institutions

Publications per year

2017–2026

11

Parents

Publications

15

The Food and Drug Administration Amendments Act and Postmarketing Commitments

Kevin M. Fain, Matthew Daubresse, G. Caleb Alexander · JAMA · 2013 · 60 citations

, , +11

Efficacy and Safety of Sunitinib in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumours

Éric Raymond, Matthew H. Kulke, Shukui Qin et al. · Neuroendocrinology · 2018 · 55 citations · Full text

, , +15

Safety and effectiveness of alectinib in a real‐world surveillance study in patients with <i><scp>ALK</scp></i>‐positive non–small‐cell lung cancer in Japan

Noriyuki Masuda, Yuichiro Ohe, Akihiko Gemma et al. · Cancer Science · 2019 · 32 citations · Full text

, , +16

Strategies and Assays for the Assessment of Unwanted Immunogenicity

Meenu Wadhwa, Robin Thorpe · Journal of Immunotoxicology · 2006 · 26 citations · Full text

, , +17

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

Joshua D. Wallach, Anita T. Luxkaranayagam, Sanket S. Dhruva et al. · BMC Medicine · 2019 · 26 citations · Full text

, , +15

1–5 of 15

Authors

79

  1. SS
    Sanket S. Dhruva

    University of California, San Francisco, United States

    3 publications · 72 citations

    3

    h-index

  2. JS
    Joseph S. Ross

    Yale University, United States

    3 publications · 72 citations

    3

    h-index

  3. JD
    Joshua D. Wallach

    Yale University, United States

    3 publications · 72 citations

    3

    h-index

  4. AT
    Anita T. Luxkaranayagam

    University of Connecticut, United States

    2 publications · 50 citations

    2

    h-index

  5. JJ
    Joshua J. Skydel

    Yale University, United States

    2 publications · 46 citations

    2

    h-index

1–5 of 79

Institutions

57

  1. Yale University

    New Haven, United States

    4 h-index

    4 publications

    83 citations

  2. Yale New Haven Hospital

    New Haven, United States

    3 h-index

    3 publications

    72 citations

  3. University of California, San Francisco

    San Francisco, United States

    3 h-index

    3 publications

    72 citations

  4. San Francisco VA Health Care System

    San Francisco, United States

    3 h-index

    3 publications

    72 citations

  5. University of Connecticut

    Storrs, United States

    2 h-index

    2 publications

    50 citations

  6. Tufts University

    Medford, United States

    2 h-index

    2 publications

    46 citations

  7. Kaiser Permanente

    Oakland, United States

    2 h-index

    2 publications

    35 citations

  8. Harvard University

    Cambridge, United States

    2 h-index

    2 publications

    25 citations

1–8 of 57

Venues

  1. JAMA

    1 publications · 60 citations

    1

    h-index

  2. Neuroendocrinology

    1 publications · 55 citations

    1

    h-index

  3. Cancer Science

    1 publications · 32 citations

    1

    h-index

  4. Journal of Immunotoxicology

    1 publications · 26 citations

    1

    h-index

  5. Expert Review of Anticancer Therapy

    1 publications · 26 citations

    1

    h-index

1–5