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The top documents tagged [fda advisory committee]
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fda advisory committee
PPT
1.584 views
Stem Cells, Building Blocks for Tissue Engineering
660 views
Research-Based Consumer Advocacy: Data Analyses Facilitate Early Warnings to Patients, Withdrawals of Dangerous Drugs Sidney M. Wolfe MD Public Citizens.
215 views
Statistical Considerations for Implementing the FDA CV Guidance for T2DM Craig Wilson, PhD NIC-ASA Fall Meeting October 15, 2009.
214 views
1 Post-Marketing Surveillance: Passive and Active Approaches and Use of Electronic Databases Karen Midthun, MD, Deputy Director Center for Biologics Evaluation.
214 views
Antithrombotic Drugs World Industry 2014-2024
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LEARNING WHICH REGULATORY STANDARDS ARE NON-STANDARD Bert Spilker, PhD, MD President, Bert Spilker & Associates.
224 views
1 FDA Advisory Committee March 6, 2003 Dennis M. Erb, PhD Regulatory Affairs Merck Research Laboratories EMEND ® (aprepitant)
216 views
Confidential Attorney Work Product Houston 713.623.0887 ● Dallas 214.237.4300 E-Discovery: The New Demands of a Wireless World Lisa Ketai.
221 views
Outline General endpoint considerations Surrogate endpoints Composite endpoints and recurrent events Safety outcomes (adverse events)
237 views
Pharmaceutical Nomenclature Issues and challenges Moheb M. Nasr, Ph.D. Acting Director Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee.
214 views
Statistical Issues in the Design, Conduct and Analysis of Large Safety Studies Michael Gaffney, PhD Pfizer Inc.
219 views
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