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Documents Clinical Review Process: An FDA Perspective Karen Midthun, M.D. Deputy Director of Medicine Center.....

Slide 1 Clinical Review Process: An FDA Perspective Karen Midthun, M.D. Deputy Director of Medicine Center for Biologics Evaluation and Research FDA April 15, 2005 Slide…

Documents CMC Review and Manufacturing (CGMP) in Investigational Products

CMC Review and Manufacturing (CGMP) in Investigational Products Chris Joneckis, Ph.D. Senior Advisor For CMC Issues Center For Biologics Evaluation And Research Add FDA Bar…