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The top documents tagged [fda advisory committee]
PPT
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Research-Based Consumer Advocacy: Data Analyses Facilitate Early Warnings to Patients, Withdrawals of Dangerous Drugs Sidney M. Wolfe MD Public Citizens
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Statistical Considerations for Implementing the FDA CV Guidance for T2DM Craig Wilson, PhD NIC-ASA Fall Meeting October 15, 2009
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1 Post-Marketing Surveillance: Passive and Active Approaches and Use of Electronic Databases Karen Midthun, MD, Deputy Director Center for Biologics Evaluation
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COMMISSION STATISTICS Claims Continue To Decline 2013 – 10,772 2012 – 11,246 1994 – 20,557
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LEARNING WHICH REGULATORY STANDARDS ARE NON-STANDARD Bert Spilker, PhD, MD President, Bert Spilker & Associates
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1 FDA Advisory Committee March 6, 2003 Dennis M. Erb, PhD Regulatory Affairs Merck Research Laboratories EMEND ® (aprepitant)
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Outline General endpoint considerations Surrogate endpoints Composite endpoints and recurrent events Safety outcomes (adverse events)
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Pharmaceutical Nomenclature Issues and challenges Moheb M. Nasr, Ph.D. Acting Director Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee
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