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- FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trialsIndustry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies.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 advisory panel debates allowing compounding pharmacies to produce seven peptidesThe FDA’s advisory committee spent two days reviewing whether compounding pharmacies should be permitted to manufacture a set of seven peptide products. The discussion involved both committee membe…