Concepedia

Accelerated Approval Pathways

Accelerated Approval Pathways is a drug regulatory approval pathway that permits earlier marketing authorization for therapies addressing serious or life-threatening conditions with unmet medical need on the basis of surrogate or intermediate clinical endpoints reasonably likely to predict clinical benefit, subject to the completion of postmarketing confirmatory studies and potential withdrawal if benefit is not verified.

131

Publications

6.5K

Citations

398

Authors

243

Institutions

Publications per year

2017–2026

78

Parents

Children

Publications

131

End Points and United States Food and Drug Administration Approval of Oncology Drugs

John R. Johnson, Grant Williams, Richard Pazdur · Journal of Clinical Oncology · 2003 · 480 citations

, , +15

Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer

Tatiana M. Prowell, Richard Pazdur · New England Journal of Medicine · 2012 · 341 citations

, , +10

Surrogate Endpoints And FDA’s Accelerated Approval Process

Thomas R. Fleming · Health Affairs · 2005 · 248 citations

, , +16

FDA Drug Approval Summary: Panitumumab (Vectibix™)

Ruthann M. Giusti, Kaushikkumar A. Shastri, Martin H. Cohen et al. · The Oncologist · 2007 · 216 citations

, , +14

Trametinib: First Global Approval

Cameron J. M. Wright, Paul L. McCormack · Drugs · 2013 · 207 citations

, , +6

1–5 of 131

Authors

398

  1. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    14 publications · 1.1K citations

    14

    h-index

  2. RP
    Richard Pazdur

    United States Food and Drug Administration, United States

    9 publications · 1.4K citations

    9

    h-index

  3. JS
    Joseph S. Ross

    Yale University, United States

    8 publications · 330 citations

    8

    h-index

  4. JJ
    Jonathan J. Darrow

    Brigham and Women's Hospital, United States

    5 publications · 345 citations

    5

    h-index

  5. HN
    Huseyin Naci

    London School of Economics and Political Science, United Kingdom

    4 publications · 356 citations

    4

    h-index

1–5 of 398

Institutions

243

  1. Brigham and Women's Hospital

    Boston, United States

    14 h-index

    39 publications

    2.9K citations

  2. Harvard University

    Cambridge, United States

    14 h-index

    33 publications

    2.4K citations

  3. United States Food and Drug Administration

    Silver Spring, United States

    10 h-index

    38 publications

    4.2K citations

  4. Center for Drug Evaluation and Research

    Silver Spring, United States

    10 h-index

    44 publications

    5K citations

  5. Yale University

    New Haven, United States

    9 h-index

    16 publications

    752 citations

  6. University of Pennsylvania

    Philadelphia, United States

    6 h-index

    13 publications

    256 citations

  7. London School of Economics and Political Science

    London, United Kingdom

    4 h-index

    6 publications

    638 citations

  8. University of Toronto

    Toronto, Canada

    4 h-index

    5 publications

    148 citations

1–8 of 243

Venues

  1. New England Journal of Medicine

    NEJM · 10 publications · 881 citations

    10

    h-index

  2. JAMA

    7 publications · 456 citations

    7

    h-index

  3. JAMA Health Forum

    6 publications · 148 citations

    6

    h-index

  4. Drug Information Journal

    DIA · 5 publications · 89 citations

    5

    h-index

  5. JAMA Network Open

    4 publications · 176 citations

    4

    h-index

1–5