PPT
Stem Cells, Building Blocks for Tissue Engineering
Research-Based Consumer Advocacy: Data Analyses Facilitate Early Warnings to Patients, Withdrawals of Dangerous Drugs Sidney M. Wolfe MD Public Citizens.
Statistical Considerations for Implementing the FDA CV Guidance for T2DM Craig Wilson, PhD NIC-ASA Fall Meeting October 15, 2009.
1 Post-Marketing Surveillance: Passive and Active Approaches and Use of Electronic Databases Karen Midthun, MD, Deputy Director Center for Biologics Evaluation.
COMMISSION STATISTICS Claims Continue To Decline 2013 – 10,772 2012 – 11,246 1994 – 20,557.
Antithrombotic Drugs World Industry 2014-2024
LEARNING WHICH REGULATORY STANDARDS ARE NON-STANDARD Bert Spilker, PhD, MD President, Bert Spilker & Associates.
1 FDA Advisory Committee March 6, 2003 Dennis M. Erb, PhD Regulatory Affairs Merck Research Laboratories EMEND ® (aprepitant)
Confidential Attorney Work Product Houston 713.623.0887 ● Dallas 214.237.4300 E-Discovery: The New Demands of a Wireless World Lisa Ketai.
Outline General endpoint considerations Surrogate endpoints Composite endpoints and recurrent events Safety outcomes (adverse events)
Pharmaceutical Nomenclature Issues and challenges Moheb M. Nasr, Ph.D. Acting Director Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee.
