Concepedia

Post-approval Commitments

Post-Approval Commitments is a formal regulatory obligation, falling under the category of health authority oversight mechanisms, that requires a pharmaceutical sponsor to conduct additional studies or surveillance activities after a product has received marketing authorization to further evaluate its safety, efficacy, or optimal use.

7

Publications

281

Citations

42

Authors

43

Institutions

Publications per year

2017–2026

5

Parents

Publications

7

CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

Enriqueta Felip, Andrea Ardizzoni, Tudor–Eliade Ciuleanu et al. · European Journal of Cancer · 2020 · 162 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

Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments

Joshua J. Skydel, Anita T. Luxkaranayagam, Sanket S. Dhruva et al. · JAMA Network Open · 2019 · 24 citations · Full text

, , +16

The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs

Rick A. Vreman, Lourens T. Bloem, Stijn van Oirschot et al. · International Journal of Health Policy and Management · 2020 · 24 citations · Full text

, , +14

The StarLink Case: Issues for the Future

M. Scott Taylor, Jody Tick · RePEc: Research Papers in Economics · 2001 · 19 citations

, , +17

1–5 of 7

Authors

42

  1. SS
    Sanket S. Dhruva

    University of California, San Francisco, United States

    2 publications · 50 citations

    2

    h-index

  2. JD
    Joshua D. Wallach

    Yale University, United States

    2 publications · 50 citations

    2

    h-index

  3. JS
    Joseph S. Ross

    Yale University, United States

    2 publications · 50 citations

    2

    h-index

  4. AT
    Anita T. Luxkaranayagam

    University of Connecticut, United States

    2 publications · 50 citations

    2

    h-index

  5. SV
    Stijn van Oirschot

    Utrecht University, Netherlands

    1 publications · 24 citations

    1

    h-index

1–5 of 42

Institutions

43

  1. University of Connecticut

    Storrs, United States

    2 h-index

    2 publications

    50 citations

  2. Yale University

    New Haven, United States

    2 h-index

    6 publications

    152 citations

  3. San Francisco VA Health Care System

    San Francisco, United States

    2 h-index

    2 publications

    50 citations

  4. University of California, San Francisco

    San Francisco, United States

    2 h-index

    2 publications

    50 citations

  5. Tufts University

    Medford, United States

    2 h-index

    3 publications

    48 citations

  6. Yale New Haven Hospital

    New Haven, United States

    2 h-index

    2 publications

    50 citations

  7. Medical University of Lublin

    Lublin, Poland

    1 h-index

    1 publications

    162 citations

  8. Ziekenhuisnetwerk Antwerpen Stuivenberg

    Antwerp, Belgium

    1 h-index

    1 publications

    162 citations

1–8 of 43

Venues

  1. RePEc: Research Papers in Economics

    Repository · 1 publications · 19 citations

    1

    h-index

  2. The Oncologist

    1 publications · 14 citations

    1

    h-index

  3. European Journal of Cancer

    1 publications · 162 citations

    1

    h-index

  4. Drug Information Journal

    DIA · 1 publications · 12 citations

    1

    h-index

  5. JAMA Network Open

    1 publications · 24 citations

    1

    h-index

1–5