REGULATORY
ICH Reaches Agreement to Treat Subjects with Similar Ethnic Factors as Single Populations Regardless of Nationality
The International Council for Harmonization (ICH) agreed to include an idea of “pooled populations” in its E17 Guideline (Multi-Regional Clinical Trials) at its meeting in Jacksonville, Florida, an official of the Pharmaceuticals and Medical Devices Agency (PMDA) said in a…
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





