Food and Drug Administration
Clinical Pharmacology Subcommittee
November 4, 2004
Slides
Presentation by Dr. Terry Blaschke, MD (HTM) (PPT)
Transition of Biomarkers to Surrogate Endpoints: A Critical Path Initiative.....Introduction, Dr. Lawrence Lesko, PhD, FCP, FDA (HTM)(PPT)
A Framework for Biomarker and Surrogate Endpoint Use in Drug Development, Dr. Janet Woodcock, MD, FDA (HTM) (PPT)
Development of Biomarkers for Decision-Making in the Development and Regulatory Evaluation of New Drugs, Dr. John Wagner, MD, PnD, PhRMA Biomarker and Genomics Working Groups (HTM) (PPT)