Concepedia

Product Approval Processes

Product Approval Processes is a formal systematic framework within regulatory and quality management systems that defines the structured procedures and criteria required to evaluate, verify, and authorize the release of a product, distinguishing it by its integration of compliance validation, risk assessment, and stakeholder consensus specific to regulated domains such as life insurance or pharmaceutical supply chains.

34

Publications

4.3K

Citations

97

Authors

55

Institutions

Publications per year

2017–2026

9

Parents

Publications

34

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

Health and Quality of Life Outcomes · 2006 · 2.9K citations · Full text

, , +16

Protection without Capture: Product Approval by a Politically Responsive, Learning Regulator

Daniel Carpenter · American Political Science Review · 2004 · 216 citations

, , +17

Lords of the Harvest: Third-Party Influence and Regulatory Approval of Genetically Modified Organisms

Shon R. Hiatt, Sangchan Park · Academy of Management Journal · 2012 · 188 citations · Full text

, , +17

Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs

Jonathan J. Darrow, Ameet Sarpatwari, Jerry Avorn et al. · New England Journal of Medicine · 2015 · 146 citations · Full text

, , +17

Halal certification in Indonesia; history, development, and implementation

Hayyun Durrotul Faridah · Journal of Halal Product and Research · 2019 · 125 citations · Full text

, , +11

1–5 of 34

Authors

97

  1. JA
    Jerry Avorn

    Brigham and Women's Hospital, United States

    2 publications · 159 citations

    2

    h-index

  2. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    2 publications · 159 citations

    2

    h-index

  3. RT
    R. T. Rynbrandt

    Columbia University, United States

    1 publications · 26 citations

    1

    h-index

  4. RA
    Richard A. Wysk

    Pennsylvania State University, United States

    1 publications · 89 citations

    1

    h-index

  5. CA
    C. Acquadro

    Mapi Research Trust, France

    1 publications · 36 citations

    1

    h-index

1–5 of 97

Institutions

55

  1. Harvard University

    Cambridge, United States

    3 h-index

    12 publications

    701 citations

  2. Harvard University Press

    Cambridge, United States

    3 h-index

    6 publications

    508 citations

  3. Brigham and Women's Hospital

    Boston, United States

    2 h-index

    11 publications

    675 citations

  4. Association of American Medical Colleges

    Washington, United States

    1 h-index

    1 publications

    18 citations

  5. Mapi Research Trust

    Lyon, France

    1 h-index

    4 publications

    144 citations

  6. University of Stuttgart

    Stuttgart, Germany

    1 h-index

    1 publications

    12 citations

  7. MGH Institute of Health Professions

    Boston, United States

    1 h-index

    1 publications

    13 citations

  8. Gates Foundation

    Seattle, United States

    1 h-index

    5 publications

    350 citations

1–8 of 55

Venues

  1. PubMed

    Repository · 3 publications · 61 citations

    3

    h-index

  2. SSRN Electronic Journal

    Repository · 2 publications · 27 citations

    2

    h-index

  3. PLoS ONE

    2 publications · 83 citations

    2

    h-index

  4. Journal of Engineering Design

    1 publications · 89 citations

    1

    h-index

  5. IOP Conference Series Materials Science and Engineering

    Conference · 1 publications · 12 citations

    1

    h-index

1–5