14 research outputs found
Clinical Development of Biologics Approved by the US Food and Drug Administration, 2003-2016
No full textAcquiring orphans
No full textCellular mechanisms in basic and clinical gastroenterology and hepatolog
Pre—Investigational New Drug Meetings With the FDA: Evaluation of Meeting Content and Characteristics of Applications for New Drug and Biologic Products
No full textEfficacy of N-carbamoyl-L-glutamic acid for the treatment of inherited metabolic disorders
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Important Role of Translational Science in Rare Disease Innovation, Discovery, and Drug Development
No full textPharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling
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