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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
BackgroundThe 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.
MethodsScenario analysis was used for the study which included: 1.New indication, 2.New combination product and 3.Rx-to-OTC switching.
ResultsIn this study, we will focus on evaluating the.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.
Last update 4 October 2019