PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
REGULATORY
Humanitarian Trial Data Will Be Supplementary Reference to Confirmatory Studies: Govt
Data from so-called “humanitarian trials,” or the Japanese version of a compassionate use system, will be used as material to supplement the results of confirmatory studies as they will be designed as single-group programs without control arms, the government said…
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