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- FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trialsIndustry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies.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- FDA offers updated guidance for generics of weight loss blockbustersThe FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's Zepbound and Novo Nordisk's Ozempic…