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The top documents tagged [regulatory perspective]
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A Regulatory Perspective on Design and Analysis of Combination Drug Trial* H.M. James Hung Division of Biometrics I, Office of Biostatistics OPaSS, CDER,
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Non-randomized Medical Device Clinical Studies: A Regulatory Perspective Sep. 16, 2005 Lilly Yue, Ph.D.* CDRH, FDA, Rockville MD 20850 * No official support
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James Hung, 2004 FDA/Industry Management of Missing Data in Clinical Trials from a Regulatory Perspective H.M. James Hung Div. of Biometrics I, OB/OPaSS/CDER/FDA
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