Concepedia

Conditional Approval Strategy

A "Conditional Approval Strategy" is a regulatory strategy that, as a genus, belongs to the class of approval mechanisms employed by regulatory authorities, and, by differentia, is distinguished by permitting the preliminary authorization of a product or intervention based on preliminary or surrogate evidence of efficacy, contingent upon the subsequent submission of confirmatory data to verify safety and effectiveness.

17

Publications

753

Citations

98

Authors

73

Institutions

Publications per year

2017–2026

8

Parents

Publications

17

Delamanid: A new armor in combating drug-resistant tuberculosis

Alphienes Stanley Xavier, Mageshwaran Lakshmanan · Journal of Pharmacology and Pharmacotherapeutics · 2014 · 143 citations · Full text

, , +15

The FDA and Drug Safety

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

, , +16

Incremental cost per quality-adjusted life year gained? The need for alternative methods to evaluate medical interventions for ultra-rare disorders

Michael Schlander, Silvio Garattini, Søren Holm et al. · Journal of Comparative Effectiveness Research · 2014 · 71 citations · Full text

, , +17

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

1–5 of 17

Authors

98

  1. HM
    Haruna Miyazawa

    Niigata University, Japan

    1 publications · 20 citations

    1

    h-index

  2. PL
    Peter L. Kolominsky‐Rabas

    Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany

    1 publications · 71 citations

    1

    h-index

  3. IO
    Isaku Okamoto

    Tokyo Medical University, Japan

    1 publications · 25 citations

    1

    h-index

  4. HS
    Huub Schellekens

    Utrecht University, Netherlands

    1 publications · 58 citations

    1

    h-index

  5. SN
    Shin‐ichi Nihira

    Kobe University, Japan

    1 publications · 32 citations

    1

    h-index

1–5 of 98

Institutions

73

  1. KU Leuven

    Leuven, Belgium

    2 h-index

    3 publications

    139 citations

  2. University Hospital Heidelberg

    Heidelberg, Germany

    2 h-index

    3 publications

    149 citations

  3. University of Groningen

    Groningen, The Netherlands

    2 h-index

    5 publications

    263 citations

  4. Pharmaceuticals and Medical Devices Agency

    Tokyo, Japan

    2 h-index

    5 publications

    148 citations

  5. Heidelberg University

    Heidelberg, Germany

    2 h-index

    3 publications

    149 citations

  6. CTI BioPharma (United States)

    Seattle, United States

    1 h-index

    2 publications

    34 citations

  7. University of Oslo

    Oslo, Norway

    1 h-index

    1 publications

    71 citations

  8. Peking University

    Beijing, China

    1 h-index

    3 publications

    69 citations

1–8 of 73

Venues

  1. Case Reports in Oncology

    1 publications · 25 citations

    1

    h-index

  2. Archives of Internal Medicine

    1 publications · 82 citations

    1

    h-index

  3. Journal of Comparative Effectiveness Research

    JCER · 1 publications · 71 citations

    1

    h-index

  4. 1

    h-index

  5. 1

    h-index

1–5