Development and Approval of Drugs and Devices EPI260 Lecture 9 May 23, 2012 Richard Chin, M.D. Overview Outline. Overview Classification Case study Reporting requirements for FDA, EMEA, and others Signal detection REMS and postmarketing surveillance. Overview Patient Safety.
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Development and Approval ofDrugs and DevicesEPI260 Lecture 9May 23, 2012Richard Chin, M.D.
Lumping and Splitting
p = NS
p = NS
p = 0.02