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
Guidance on Companion Diagnostics Calls for Inclusion of Biomarker-Negative Subjects in Clinical Studies
The Pharmaceutical and Food Safety Bureau’s Evaluation and Licensing Division has issued a technical guidance on the development of companion diagnostics (CoDx) and related drugs to prefectures. The guidance covers items to keep in mind when developing drugs and CoDx…
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REGULATORY
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