Concepedia

Drug Approval

Drug Approval is a regulatory decision process within pharmaceutical governance that authorizes the commercialization of a medicinal product following demonstration of its safety, efficacy, and quality in accordance with established legal and scientific standards.

2.2K

Publications

98.2K

Citations

5.3K

Authors

1.9K

Institutions

Publications per year

2017–2026

747

Variants

Drug Marketing AuthorizationPharmaceutical Approval

Parents

Children

Publications

2.2K

Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018

Olivier J. Wouters, Martin McKee, Jeroen Luyten · JAMA · 2020 · 1.5K citations · Full text

, , +17

The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

Stan Benjamens, Pranavsingh Dhunnoo, Bertalan Meskó · npj Digital Medicine · 2020 · 1.1K citations · Full text

, , +9

The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy

Art Van Zee · American Journal of Public Health · 2008 · 904 citations · Full text

, , +17

International conference on harmonization of technical requirements for registration of pharmaceuticals for human use

Jatinder Singh · Journal of Pharmacology and Pharmacotherapeutics · 2015 · 897 citations

, , +14

An analysis of FDA-approved drugs: natural products and their derivatives

Eric Patridge, Peter C. Gareiss, Michael S. Kinch · Drug Discovery Today · 2015 · 819 citations

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1–5 of 2.2K

Authors

5.3K

  1. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    81 publications · 4.7K citations

    40

    h-index

  2. JS
    Joseph S. Ross

    Yale University, United States

    39 publications · 2.2K citations

    24

    h-index

  3. JA
    Jerry Avorn

    Brigham and Women's Hospital, United States

    28 publications · 1.7K citations

    20

    h-index

  4. HG
    Hubert G. M. Leufkens

    Utrecht University, Netherlands

    20 publications · 892 citations

    17

    h-index

  5. HN
    Huseyin Naci

    London School of Economics and Political Science, United Kingdom

    15 publications · 800 citations

    15

    h-index

1–5 of 5.3K

Institutions

1.9K

  1. Brigham and Women's Hospital

    Boston, United States

    44 h-index

    250 publications

    15.4K citations

  2. United States Food and Drug Administration

    Silver Spring, United States

    41 h-index

    360 publications

    18.6K citations

  3. Harvard University

    Cambridge, United States

    40 h-index

    217 publications

    13.4K citations

  4. Center for Drug Evaluation and Research

    Silver Spring, United States

    36 h-index

    306 publications

    16.1K citations

  5. Yale University

    New Haven, United States

    26 h-index

    100 publications

    6.9K citations

  6. Tufts University

    Medford, United States

    26 h-index

    85 publications

    4.4K citations

  7. Utrecht University

    Utrecht, The Netherlands

    25 h-index

    113 publications

    4.5K citations

  8. London School of Economics and Political Science

    London, United Kingdom

    23 h-index

    68 publications

    4.3K citations

1–8 of 1.9K

Venues

  1. New England Journal of Medicine

    NEJM · 80 publications · 5.9K citations

    42

    h-index

  2. PubMed

    Repository · 139 publications · 4.8K citations

    37

    h-index

  3. Clinical Pharmacology & Therapeutics

    CPT · 88 publications · 4K citations

    34

    h-index

  4. Drugs

    34 publications · 3.1K citations

    31

    h-index

  5. JAMA

    58 publications · 5.4K citations

    28

    h-index

1–5