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On May 20, 2022, Cathy McMorris Rodgers, member of the.
The email expressed concern about the increase in the number of clinical trials being conducted in Chi.
Finally, FDA is urged to respond to the following questions by June 3, 2022:How many biologics license applications or drug applications have been received by FDA based solely on or primarily based on clinical trials in China?Before the epidemic, between January 1, 2017 and January 1, 2020, how many clinical trial sites in China were inspected by the FDA? What are the results of these checks?How many clinical trial centers in China have been identified as involving data withdrawal in their application to the FDA? What efforts are required to address data integrity issues? Do any of these centers contribute significant numbers of patients in international, multi-regional clinical trials submitted to regulatory agencies, especially the FDA?
