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DIA Montreal: June 1997
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CDER Guidance and Processes for Electronic Regulatory Submissions for Archive: David Isom
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CDER Transformation Process: Janet Woodcock, M.D.
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A Collaborative Approach to Drug Development: A New Division's Proactive Processes: Lana L. Pauls, M.P.H.
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Computers in Clinical Trials Draft Guidance - Implications Stan W. Woollen
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Computers in Clinical Trials Draft Guidance - Introduction David A. Lepay, MD, PhD
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The Future of Electronic Submissions: Janet Woodcock, M.D.
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Progress and Challenges for the U.S. Drug Regulatory System: Janet Woodcock, M.D.
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A Shift in the Regulatory Approach: Janet Woodcock, M.D.
Last update: July 13, 2005 |
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