Evolving Real-World Data and Evidence Use for New Drugs and Regenerative Medical Products Approvals in Japan-An Analysis of the 6-Year Trend.

Similarly, a systematic review of FDA approval documents from 2019 to 2021 reported an increasing trend of approvals incorporating RWD/E. 2 More recently, a targeted review characterized 85 use cases of RWD/E submitted to the FDA and EMA. 16 However, evidence showing how the use of RWD/E evolved along with the development of regulatory initiatives is limited.

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