Food and Drug Administration

Science Board Advisory Committee

April 9, 2003

Slides

Quality Systems and the Medical Product Review Process, Dr. Janet Woodcock, MD, FDA (HTM) (PPT)

Quality Teams and Regulatory Review, Dr. David Feigal, MD, MPH, FDA (HTM) (PPT)

Quality Systems for Clinical Pharmacology and Biopharmaceutics Review, Dr. Lawrence Lesko, PhD, FDA (HTM) (PPT)

Quality Systems for Product Quality (CMC) Review, Dr. Yuan-Yuan Chiu, PhD, FDA (HTM) (PPT)

Update on Pharmaceutical Manufacturing Initiative, Dr. Ajaz Hussuan, PhD, FDA (HTM) (PPT)

Patient Safety Initiatives, Kelly Cronin, FDA (HTM) (PPT)

Integrating Scientific Advances into Regulation: Pharmacogenomics and Pharmacogenetics, Dr. Janet Woodcock, MD, FDA (HTM) (PPT)

Pharmacogenomics in Drug Development, Dr. Brian Sear, PhD, Abbott Laboratories (HTM) (PPT)

Applications of Genomic Technologies to Improve Recognition, Understanding, and Assessment of Pharmaceutical Actions: A Focus on Integrating Gene Expression Data Sets into Regulatory Practice, Frank Sistare, FDA (HTM) (PPT)

Pharmacogenetics (PG): Drug Metabolism and Dosage, Dr. Lawrence Lesko, PhD, FDA (HTM) (PPT)

Ethical Issues With the Regulatory Use of Gene Expressions Data, Dr. Benjamin Wilfond, MD, Nat'l Human Genome Research Institute (HTM) (PPT)