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The top documents tagged [fda review staff]
New drug application
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Ind (investigational new drug application) and nda
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FDA and Patient Interactions On Benefit-Risk Determinations
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Apheresis Blood Components Lore Fields, MT(ASCP)SBB Consumer Safety Officer, DBA, OBRR, CBER September 16, 2009
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FDA Recommendations: Sampling Plans for Blood Establishments Lore Fields MT(ASCP)SBB Consumer Safety Officer OBRR/CBER/FDA October 19, 2012
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Donor deferral due to intake of anti-platelet medication Sharyn Orton, Ph.D. Jaro Vostal, M.D., Ph.D. OBRR/CBER/FDA Blood Products Advisory Committee Meeting
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Leukocyte-Reduced Blood Components Lore Fields MT(ASCP)SBB Consumer Safety Officer, DBA, OBRR, CBER September 16, 2009
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The FDA Review Process
81 views