The top documents tagged [fda advisory committee]

PPT
Documents PPT

1.584 views

Stem Cells, Building Blocks for Tissue Engineering
Documents Stem Cells, Building Blocks for Tissue Engineering

661 views

Research-Based Consumer Advocacy: Data Analyses Facilitate Early Warnings to Patients, Withdrawals of Dangerous Drugs Sidney M. Wolfe MD Public Citizens
Documents 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
Documents 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
Documents 1 Post-Marketing Surveillance: Passive and Active Approaches and Use of Electronic Databases Karen Midthun, MD, Deputy Director Center for Biologics Evaluation

214 views

COMMISSION STATISTICS Claims Continue To Decline 2013 – 10,772 2012 – 11,246 1994 – 20,557
Documents COMMISSION STATISTICS Claims Continue To Decline 2013 – 10,772 2012 – 11,246 1994 – 20,557

216 views

Antithrombotic Drugs World Industry 2014-2024
Business Antithrombotic Drugs World Industry 2014-2024

530 views

LEARNING WHICH REGULATORY STANDARDS ARE NON-STANDARD Bert Spilker, PhD, MD President, Bert Spilker & Associates
Documents LEARNING WHICH REGULATORY STANDARDS ARE NON-STANDARD Bert Spilker, PhD, MD President, Bert Spilker & Associates

227 views

1 FDA Advisory Committee March 6, 2003 Dennis M. Erb, PhD Regulatory Affairs Merck Research Laboratories EMEND ® (aprepitant)
Documents 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
Documents Confidential Attorney Work Product Houston 713.623.0887 ● Dallas 214.237.4300 E-Discovery: The New Demands of a Wireless World Lisa Ketai

225 views

Outline General endpoint considerations Surrogate endpoints Composite endpoints and recurrent events Safety outcomes (adverse events)
Documents Outline General endpoint considerations Surrogate endpoints Composite endpoints and recurrent events Safety outcomes (adverse events)

239 views

Pharmaceutical Nomenclature Issues and challenges Moheb M. Nasr, Ph.D. Acting Director Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee
Documents Pharmaceutical Nomenclature Issues and challenges Moheb M. Nasr, Ph.D. Acting Director Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee

215 views