Korea FDA Prepares Guidelines On Phase 0 Clinical Trials To Draw More Early-stage Trials
This article was originally published in PharmAsia News
SEOUL - Korea FDA is gearing up to release guidelines on Phase 0 clinical trials in the first half of next year under its broader ambition to draw more early-stage clinical trials to the country
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KFDA is focusing on early-stage trials in a campaign to shorten IND approval times and draw more clinical trials to Korea
South Korean Plan To Shorten IND Approvals Raises Competition With Singapore For Clinical Trials Hub
Patient differences will come into sharper relief in attracting Phase I clinical trials if, as expected, South Korea cuts its IND approval timeline near par with Singapore.
As Korea competes with neighboring countries to be a regional clinical trial hub, KFDA weighs the advantages of slashing IND timelines from 30 days down to 14 days.