Concepedia

Conditional Approval Rules

Conditional Approval Rules is a formal set of criteria within a change approval process that specifies prerequisite conditions and contextual constraints under which a proposed change may be provisionally authorized, distinguishing it from unconditional or blanket approval mechanisms by requiring explicit fulfillment of predefined triggers, validations, or risk mitigations prior to implementation.

13

Publications

440

Citations

58

Authors

44

Institutions

Publications per year

2017–2026

8

Parents

Publications

13

The FDA and Drug Safety

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

, , +16

Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe

Wouter Boon, Ellen H.M. Moors, Albert Meijer et al. · Clinical Pharmacology & Therapeutics · 2010 · 58 citations · Full text

, , +17

Conditional Approval: Japan Lowers the Bar for Regenerative Medicine Products

Douglas Sipp · Cell stem cell · 2015 · 58 citations · Full text

, , +12

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union

Yoji Jokura, Kazuo Yano, Masayuki Yamato · Journal of Tissue Engineering and Regenerative Medicine · 2017 · 38 citations · Full text

, , +15

Early Patient Access to Medicines: Health Technology Assessment Bodies Need to Catch Up with New Marketing Authorization Methods

Lada Leyens, Angela Brand · Public Health Genomics · 2016 · 35 citations · Full text

, , +16

1–5 of 13

Authors

58

  1. HZ
    Huan Zhang

    Tianjin Medical University Cancer Institute and Hospital, China

    1 publications · 20 citations

    1

    h-index

  2. MM
    Melanie McPhail

    Simon Fraser University, Canada

    1 publications · 15 citations

    1

    h-index

  3. PZ
    Pei Zhang

    Huazhong University of Science and Technology, China

    1 publications · 20 citations

    1

    h-index

  4. CD
    Curt D. Furberg

    Wake Forest University, United States

    1 publications · 82 citations

    1

    h-index

  5. SV
    Stef Van den Branden

    KU Leuven, Belgium

    1 publications · 34 citations

    1

    h-index

1–5 of 58

Institutions

44

  1. York University

    Toronto, Canada

    1 h-index

    1 publications

    15 citations

  2. Duke University

    Durham, United States

    1 h-index

    1 publications

    23 citations

  3. Simon Fraser University

    Burnaby, Canada

    1 h-index

    3 publications

    45 citations

  4. International University of Health and Welfare

    Ōtawara, Japan

    1 h-index

    1 publications

    32 citations

  5. Waseda University

    Tokyo, Japan

    1 h-index

    3 publications

    114 citations

  6. National Cancer Center Hospital East

    Kashiwa, Japan

    1 h-index

    3 publications

    96 citations

  7. China Pharmaceutical University

    Nanjing, China

    1 h-index

    5 publications

    100 citations

  8. University of Minnesota

    Minneapolis, United States

    1 h-index

    1 publications

    23 citations

1–8 of 44

Venues

  1. Clinical Pharmacology & Therapeutics

    CPT · 1 publications · 58 citations

    1

    h-index

  2. BMJ Open

    1 publications · 15 citations

    1

    h-index

  3. EClinicalMedicine

    1 publications · 23 citations

    1

    h-index

  4. International Journal of Cancer

    1 publications · 20 citations

    1

    h-index

  5. Public Health Genomics

    1 publications · 35 citations

    1

    h-index

1–5