Concepedia

Product Approval Pathways

Product Approval Pathways is a regulatory framework that specifies the procedural, evidentiary, and evaluative requirements through which a product must progress to obtain formal authorization for market entry within a defined jurisdiction.

41

Publications

1.5K

Citations

143

Authors

109

Institutions

Publications per year

2017–2026

20

Parents

Publications

41

Protection without Capture: Product Approval by a Politically Responsive, Learning Regulator

Daniel Carpenter · American Political Science Review · 2004 · 216 citations

, , +17

Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs

Jonathan J. Darrow, Ameet Sarpatwari, Jerry Avorn et al. · New England Journal of Medicine · 2015 · 146 citations · Full text

, , +17

Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe

Jacoline C. Bouvy, Claudine Sapède, Sarah Garner · Frontiers in Pharmacology · 2018 · 71 citations · Full text

, , +12

Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization

Vincent I. Ahonkhai, Samuel Martins, Alexandre Portet et al. · PLoS ONE · 2016 · 70 citations · Full text

, , +17

The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011–2018

Catherine Schuster Bruce, Petra Brhlíková, Joseph Heath et al. · PLoS Medicine · 2019 · 69 citations · Full text

, , +16

1–5 of 41

Authors

143

  1. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    4 publications · 242 citations

    4

    h-index

  2. AS
    Ameet Sarpatwari

    Brigham and Women's Hospital, United States

    2 publications · 162 citations

    2

    h-index

  3. JA
    Jerry Avorn

    Brigham and Women's Hospital, United States

    2 publications · 159 citations

    2

    h-index

  4. WG
    Wim Goettsch

    Utrecht University, Netherlands

    1 publications · 35 citations

    1

    h-index

  5. GS
    Gisbert Selke

    Wissenschaftliches Institut der AOK, Germany

    1 publications · 55 citations

    1

    h-index

1–5 of 143

Institutions

109

  1. Harvard University

    Cambridge, United States

    7 h-index

    20 publications

    984 citations

  2. Brigham and Women's Hospital

    Boston, United States

    5 h-index

    18 publications

    956 citations

  3. Utrecht University

    Utrecht, The Netherlands

    2 h-index

    5 publications

    156 citations

  4. Zorginstituut Nederland

    Diemen, The Netherlands

    2 h-index

    3 publications

    145 citations

  5. University of Toronto

    Toronto, Canada

    2 h-index

    2 publications

    44 citations

  6. Harvard University Press

    Cambridge, United States

    2 h-index

    2 publications

    226 citations

  7. Western University

    London, Canada

    1 h-index

    3 publications

    60 citations

  8. Cornell University

    Ithaca, United States

    1 h-index

    1 publications

    17 citations

1–8 of 109

Venues

  1. PubMed

    Repository · 4 publications · 78 citations

    4

    h-index

  2. Frontiers in Pharmacology

    2 publications · 126 citations

    2

    h-index

  3. PLoS ONE

    2 publications · 83 citations

    2

    h-index

  4. Biologics

    1 publications · 15 citations

    1

    h-index

  5. New England Journal of Medicine

    NEJM · 1 publications · 146 citations

    1

    h-index

1–5