Shanghai Life Sciences Partner Addresses China FDA Guidelines for Using Foreign Medical Device Clinical Trial Data
Life sciences partner Katherine Wang (Shanghai) was quoted in a Jan. 22 article in International Devices & Diagnostics Monitor addressing China FDA guidelines for accepting clinical trial data for medical device trials conducted overseas.
Ms. Wang explains that CFDA guidelines are aimed at accelerating and simplifying the medical device approval process. She notes that foreign devicemakers seeking to bypass local trials should involve sufficient numbers of Chinese patients when organizing their clinical studies.