Concepedia

Regulatory Timelines

Regulatory Timelines is a structured framework within the domain of pharmaceutical regulation that specifies the sequential milestones, deadlines, and review periods governing the evaluation and approval processes for market authorization of medicinal products.

63

Publications

1.9K

Citations

208

Authors

119

Institutions

Publications per year

2017–2026

28

Parents

Publications

63

Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012

Leonard Sacks, Hala Shamsuddin, Yuliya Yasinskaya et al. · JAMA · 2014 · 214 citations

, , +13

Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD

Jayne E. Hastedt, Per Bäckman, Andrew Clark et al. · AAPS Open · 2016 · 110 citations · Full text

, , +17

Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019

Mark P. Lythgoe, Aakash Desai, Bishal Gyawali et al. · JAMA Network Open · 2022 · 82 citations · Full text

, , +13

The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

Thomas J. Hwang, Jonathan J. Darrow, Aaron S. Kesselheim · JAMA · 2017 · 81 citations · Full text

, , +16

Firm Characteristics and the Speed of FDA Approval

Mary K. Olson · Journal of Economics & Management Strategy · 1997 · 56 citations

, , +13

1–5 of 63

Authors

208

  1. SS
    Sam Salek

    University of Hertfordshire, United Kingdom

    6 publications · 137 citations

    6

    h-index

  2. SW
    Stuart Walker

    Centre for Innovation in Regulatory Science, United Kingdom

    5 publications · 111 citations

    5

    h-index

  3. NS
    Nigel S. B. Rawson

    University of Saskatchewan, Canada

    4 publications · 103 citations

    4

    h-index

  4. NM
    Neil McAuslane

    Centre for Innovation in Regulatory Science, United Kingdom

    4 publications · 83 citations

    4

    h-index

  5. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    4 publications · 137 citations

    4

    h-index

1–5 of 208

Institutions

119

  1. Centre for Innovation in Regulatory Science

    London, United Kingdom

    9 h-index

    18 publications

    369 citations

  2. Tufts University

    Medford, United States

    6 h-index

    13 publications

    223 citations

  3. University of Hertfordshire

    Hatfield, United Kingdom

    6 h-index

    14 publications

    327 citations

  4. Brigham and Women's Hospital

    Boston, United States

    4 h-index

    10 publications

    435 citations

  5. Yale University

    New Haven, United States

    3 h-index

    4 publications

    79 citations

  6. Institute of Economic Development

    Warrington, United Kingdom

    2 h-index

    3 publications

    79 citations

  7. Innovative Medicines Canada

    Ottawa, Canada

    2 h-index

    4 publications

    84 citations

  8. Merck & Co., Inc., Rahway, NJ, USA (United States)

    Rahway, United States

    2 h-index

    7 publications

    398 citations

1–8 of 119

Venues

  1. Therapeutic Innovation & Regulatory Science

    TIRS · 6 publications · 137 citations

    6

    h-index

  2. Frontiers in Pharmacology

    4 publications · 96 citations

    4

    h-index

  3. Drug Information Journal

    DIA · 3 publications · 57 citations

    3

    h-index

  4. Health Affairs

    3 publications · 74 citations

    3

    h-index

  5. PubMed

    Repository · 3 publications · 70 citations

    3

    h-index

1–5