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- FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.FDA today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who…fda press · 1h ago↗ source
- 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.…