Concepedia

Premarket Registration

Premarket Registration is a formal regulatory process within chemical registration that constitutes the systematic evaluation and authorization of chemical substances prior to their commercial introduction, distinguishing it from post-market oversight by requiring proof of safety, efficacy, and compliance with established standards as a precondition for market entry.

15

Publications

590

Citations

73

Authors

34

Institutions

Publications per year

2017–2026

6

Parents

Publications

15

Regulation of Probiotic Substances as Ingredients in Foods: Premarket Approval or “Generally Recognized as Safe” Notification

Antonia Mattia, Robert I. Merker · Clinical Infectious Diseases · 2008 · 87 citations

, , +17

Five-Year Follow-Up Data from the U.S. Clinical Trial for Sientraʼs U.S. Food and Drug Administration–Approved Silimed® Brand Round and Shaped Implants with High-Strength Silicone Gel

W. Grant Stevens, Jennifer L. Harrington, Kaveh Alizadeh et al. · Plastic & Reconstructive Surgery · 2012 · 78 citations

, , +15

Brain–computer interface devices for patients with paralysis and amputation: a meeting report

Kristen A. Bowsher, Eugene F. Civillico, James Coburn et al. · Journal of Neural Engineering · 2016 · 69 citations · Full text

, , +14

FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

Benjamin N. Rome, Daniel B. Kramer, Aaron S. Kesselheim · JAMA · 2014 · 67 citations · Full text

, , +16

The current landscape of the FDA approved companion diagnostics

Jan Trøst Jørgensen · Translational Oncology · 2021 · 60 citations · Full text

, , +17

1–5 of 15

Authors

73

  1. JS
    Joseph S. Ross

    Yale University, United States

    2 publications · 69 citations

    2

    h-index

  2. AM
    Andre M. Samuel

    Yale University, United States

    1 publications · 10 citations

    1

    h-index

  3. RK
    R. Kamaraj

    1 publications · 33 citations

    1

    h-index

  4. GL
    Gretchen L. Knaack

    George Mason University, United States

    1 publications · 69 citations

    1

    h-index

  5. SS
    S Shermer

    Office of Science, United States

    1 publications · 69 citations

    1

    h-index

1–5 of 73

Institutions

34

  1. Center for Devices and Radiological Health

    Rockville, United States

    3 h-index

    21 publications

    1.3K citations

  2. United States Food and Drug Administration

    Silver Spring, United States

    2 h-index

    9 publications

    639 citations

  3. Yale University

    New Haven, United States

    2 h-index

    7 publications

    217 citations

  4. Robert Wood Johnson Foundation

    Princeton, United States

    2 h-index

    2 publications

    38 citations

  5. Brown University

    Providence, United States

    2 h-index

    3 publications

    154 citations

  6. Harvard University

    Cambridge, United States

    2 h-index

    4 publications

    270 citations

  7. Case Western Reserve University

    Cleveland, United States

    2 h-index

    6 publications

    240 citations

  8. Rehabilitation Research and Development Service

    Washington D.C., United States

    1 h-index

    1 publications

    69 citations

1–8 of 34

Venues

  1. JAMA

    3 publications · 154 citations

    3

    h-index

  2. PubMed

    Repository · 2 publications · 50 citations

    2

    h-index

  3. Journal of Dermatological Treatment

    1 publications · 11 citations

    1

    h-index

  4. Clinical Infectious Diseases

    CID · 1 publications · 87 citations

    1

    h-index

  5. Journal of Clinical Microbiology

    JCM · 1 publications · 16 citations

    1

    h-index

1–5