Concepedia

Market Authorization

Market Authorization is a regulatory determination within the domain of device regulation that classifies a medical device as meeting requisite safety, efficacy, and quality standards, thereby permitting its commercial distribution and clinical use in a defined jurisdiction.

100

Publications

3.3K

Citations

425

Authors

258

Institutions

Publications per year

2017–2026

57

Parents

Publications

100

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

Medical Devices — Balancing Regulation and Innovation

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

, , +17

The regulation of mobile medical applications

Ali K. Yetisen, J. L. Martínez-Hurtado, Fernando da Cruz Vasconcellos et al. · Lab on a Chip · 2014 · 116 citations

, , +16

Refurbishing authorization strategy in the secondary market for electrical and electronic products

Huihui Liu, Ming Lei, Tao Huang et al. · International Journal of Production Economics · 2017 · 93 citations

, , +10

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

Ioana Arina Gherghescu, M. Begoña Delgado‐Charro · Pharmaceutics · 2020 · 91 citations · Full text

, , +16

1–5 of 100

Authors

425

  1. HN
    Huseyin Naci

    London School of Economics and Political Science, United Kingdom

    3 publications · 111 citations

    3

    h-index

  2. JS
    Joseph S. Ross

    Yale University, United States

    3 publications · 77 citations

    3

    h-index

  3. MC
    Martina C. Cornel

    Amsterdam Public Health, Netherlands

    2 publications · 37 citations

    2

    h-index

  4. SS
    Stephanie S. Weinreich

    Dutch Blood Transfusion Society, Netherlands

    2 publications · 37 citations

    2

    h-index

  5. OA
    Olivia A Wackowski

    Rutgers, The State University of New Jersey, United States

    2 publications · 41 citations

    2

    h-index

1–5 of 425

Institutions

258

  1. Harvard University

    Cambridge, United States

    9 h-index

    12 publications

    357 citations

  2. Brigham and Women's Hospital

    Boston, United States

    5 h-index

    7 publications

    194 citations

  3. London School of Economics and Political Science

    London, United Kingdom

    4 h-index

    10 publications

    288 citations

  4. Zorginstituut Nederland

    Diemen, The Netherlands

    4 h-index

    5 publications

    118 citations

  5. Federal Institute for Drugs and Medical Devices

    Bonn, Germany

    3 h-index

    6 publications

    139 citations

  6. Yale University

    New Haven, United States

    3 h-index

    5 publications

    106 citations

  7. Radboud University Nijmegen

    Nijmegen, The Netherlands

    3 h-index

    3 publications

    82 citations

  8. European Medicines Agency

    Amsterdam, Netherlands

    3 h-index

    4 publications

    104 citations

1–8 of 258

Venues

  1. PubMed

    Repository · 3 publications · 64 citations

    3

    h-index

  2. Clinical Pharmacology & Therapeutics

    CPT · 3 publications · 123 citations

    3

    h-index

  3. New England Journal of Medicine

    NEJM · 3 publications · 210 citations

    3

    h-index

  4. 3

    h-index

  5. International Journal of Production Economics

    3 publications · 215 citations

    3

    h-index

1–5