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- FDA approves first freeze-dried plasma product for U.S. useThe FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
- Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selectionIndustry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…