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- FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trialsIndustry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
- WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority statusThe World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…