Use of real-world evidence for international regulatory decision making in medical devices

HIGHLIGHTS

  • who: Vicky Valla from the Copenhagen, Denmark have published the Article: Use of Real-World Evidence for International Regulatory Decision Making in Medical Devices, in the Journal: (JOURNAL) of September/15,/2022
  • what: The aim of this article is to summarize the currently available guidances, frameworks, and initiatives for the collection, management, and interpretation of RWD/R the authors around the globe, up until September 2022. The review focuses on the use of RWE/RWD and patient-reported outcomes (PROs), thereby separating these sources of evidence. The Chinese approach focuses on medicines for pediatric use . . .

     

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