Concepedia

Market Authorization Pathways

Market Authorization Pathways is a regulatory framework that defines the systematic process by which medical devices are evaluated and granted permission for commercial distribution and clinical use within a specific jurisdiction.

91

Publications

3.4K

Citations

338

Authors

226

Institutions

Publications per year

2017–2026

53

Parents

Publications

91

Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?

Robert Kemp, Vinay Prasad · BMC Medicine · 2017 · 272 citations · Full text

, , +15

Biology-inspired microphysiological systems to advance medicines for patient benefit and animal welfare

Uwe Marx · ALTEX · 2020 · 208 citations · Full text

, , +14

Erdafitinib: First Global Approval

Anthony Markham · Drugs · 2019 · 162 citations

, , +10

Medical Devices — Balancing Regulation and Innovation

Gregory Curfman, Rita F. Redberg · New England Journal of Medicine · 2011 · 144 citations

, , +17

Cell, tissue and gene products with marketing authorization in 2018 worldwide

Natividad Cuende, John E.J. Rasko, Mickey Koh et al. · Cytotherapy · 2018 · 109 citations · Full text

, , +16

1–5 of 91

Authors

338

  1. JS
    Joseph S. Ross

    Yale University, United States

    4 publications · 141 citations

    4

    h-index

  2. VK
    Vinay K. Rathi

    Massachusetts Eye and Ear Infirmary, United States

    3 publications · 93 citations

    3

    h-index

  3. HN
    Huseyin Naci

    London School of Economics and Political Science, United Kingdom

    3 publications · 111 citations

    3

    h-index

  4. HE
    Harald Enzmann

    Federal Institute for Drugs and Medical Devices, Germany

    2 publications · 75 citations

    2

    h-index

  5. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    2 publications · 99 citations

    2

    h-index

1–5 of 338

Institutions

226

  1. Harvard University

    Cambridge, United States

    7 h-index

    12 publications

    378 citations

  2. United States Food and Drug Administration

    Silver Spring, United States

    5 h-index

    16 publications

    445 citations

  3. Brigham and Women's Hospital

    Boston, United States

    4 h-index

    11 publications

    316 citations

  4. KU Leuven

    Leuven, Belgium

    4 h-index

    6 publications

    282 citations

  5. Yale University

    New Haven, United States

    4 h-index

    8 publications

    267 citations

  6. Utrecht University

    Utrecht, The Netherlands

    3 h-index

    10 publications

    492 citations

  7. Erasmus University Rotterdam

    Rotterdam, The Netherlands

    3 h-index

    4 publications

    69 citations

  8. European Medicines Agency

    Amsterdam, Netherlands

    3 h-index

    8 publications

    162 citations

1–8 of 226

Venues

  1. Clinical Pharmacology & Therapeutics

    CPT · 5 publications · 204 citations

    5

    h-index

  2. Frontiers in Pharmacology

    4 publications · 186 citations

    4

    h-index

  3. New England Journal of Medicine

    NEJM · 4 publications · 248 citations

    4

    h-index

  4. 3

    h-index

  5. Value in Health

    3 publications · 91 citations

    3

    h-index

1–5