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- FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trialsIndustry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies.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…
- FDA reminds investors about the risks of advisory panelsTwo days, two similar briefing documents and two companies with diving share prices. The FDA this week laid out its concerns with clinical data from both Capricor Therapeutics and