Concepedia

Postmarketing Commitments

Postmarketing Commitments is a regulatory requirement in pharmaceutical governance that mandates the sponsor to conduct specified studies or activities after market authorization to verify clinical benefit, monitor long-term safety, or fulfill conditions agreed upon with regulatory agencies during the priority review process.

16

Publications

1.2K

Citations

62

Authors

25

Institutions

Publications per year

2017–2026

8

Variants

Post-marketing Requirements

Parents

Publications

16

Approval Summary: Imatinib Mesylate in the Treatment of Metastatic and/or Unresectable Malignant Gastrointestinal Stromal Tumors

Martin H. Cohen, Ann T. Farrell, Robert Justice et al. · The Oncologist · 2009 · 429 citations · Full text

, , +15

Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

Huseyin Naci, Katelyn R. Smalley, Aaron S. Kesselheim · JAMA · 2017 · 190 citations · Full text

, , +17

U.S. Food and Drug Administration Drug Approval Summary: Conversion of Imatinib Mesylate (STI571; Gleevec) Tablets from Accelerated Approval to Full Approval

Martin H. Cohen, John R. Johnson, Richard Pazdur · Clinical Cancer Research · 2005 · 96 citations · Full text

, , +13

The FDA and Drug Safety

Curt D. Furberg · Archives of Internal Medicine · 2006 · 82 citations

, , +16

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021

Sundeep Agrawal, Shaily Arora, Laleh Amiri‐Kordestani et al. · JAMA Oncology · 2022 · 80 citations

, , +15

1–5 of 16

Authors

62

  1. JD
    Joshua D. Wallach

    Yale University, United States

    4 publications · 144 citations

    4

    h-index

  2. JS
    Joseph S. Ross

    Yale University, United States

    4 publications · 144 citations

    4

    h-index

  3. SS
    Sanket S. Dhruva

    University of California, San Francisco, United States

    4 publications · 144 citations

    4

    h-index

  4. RP
    Richard Pazdur

    United States Food and Drug Administration, United States

    3 publications · 605 citations

    3

    h-index

  5. MH
    Martin H. Cohen

    Center for Drug Evaluation and Research, United States

    2 publications · 525 citations

    2

    h-index

1–5 of 62

Institutions

25

  1. Yale New Haven Hospital

    New Haven, United States

    4 h-index

    6 publications

    288 citations

  2. Yale University

    New Haven, United States

    4 h-index

    9 publications

    318 citations

  3. Harvard University

    Cambridge, United States

    3 h-index

    5 publications

    277 citations

  4. United States Food and Drug Administration

    Silver Spring, United States

    3 h-index

    23 publications

    3.3K citations

  5. University of California, San Francisco

    San Francisco, United States

    3 h-index

    3 publications

    72 citations

  6. Brigham and Women's Hospital

    Boston, United States

    3 h-index

    5 publications

    277 citations

  7. San Francisco VA Health Care System

    San Francisco, United States

    3 h-index

    3 publications

    72 citations

  8. Center for Drug Evaluation and Research

    Silver Spring, United States

    3 h-index

    22 publications

    3.2K citations

1–8 of 25

Venues

  1. Vaccine

    2 publications · 66 citations

    2

    h-index

  2. JAMA

    2 publications · 250 citations

    2

    h-index

  3. Clinical Cancer Research

    2 publications · 112 citations

    2

    h-index

  4. BMJ

    1 publications · 72 citations

    1

    h-index

  5. BMC Medicine

    1 publications · 26 citations

    1

    h-index

1–5