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

• At: AbuDhabi (United Arab Emirates) (2019)
• Type: Poster
• Poster code: POS-RSC-013
• 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 21^st 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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