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USING THE REAL WORLD EVIDENCE TO SUPPORT THE REGULATION OF NEW DRUG APPLICATION IN TAIWAN.

  • At: 2019 FIP Congress in AbuDhabi (United Arab Emirates)
  • Type: Poster
  • By: WU, Bing-Shan (Merck Sharp & Dohme Corp., Medical Affairs, China Taiwan)
  • Co-author(s): Bing-Shan Wu: Department of Clinical Pharmacy, Taipei Medical University, Taipei City, China Taiwan
    Hui-Wen Cheng: Department of Clinical Pharmacy, Taipei Medical University, Taipei City, China Taiwan
    Wan Nan Yu: Department of Law, Soochow University, Taipei City, China Taiwan
  • Abstract:

    Background

    The US Senate passed the 21st Century Cures Act in 2016 where it added a new amendment into the Section 3022: “Utilizing Real-World Evidence” 1-4.

    Methods

    Scenario analysis was used for the study which included: 1.New indication, 2.New combination product and 3.Rx-to-OTC switching.

    Results

    In this study, we will focus on evaluating the

    ..

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Last update 4 October 2019

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