Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Pharmacology and Toxicology Subcommittee

June 10, 2003

Promise of "Toxicogenomics", Dr. Jacobson and Dr. Kram, FDA (HTM) (PPT)

Concept of "No Regulatory Impact" for Data Submissions, Dr. Janet Woodcock, MD, FDA (HTM) (PPT)

ILSI HESI Technical Committee on Application of Genomics to Mechanism Based Risk Assessment, Dr. Pennie, ILSI HESI (HTM) (PPT)

Submission of Microarray Data: Dealing Effectively With Data Quality Issues and Information Content Necessary to Develop an Expression Database, Dr. Jarnigan, Iconix (HTM) (PPT)

Challenges in Data Management and Analysis for Microarrays, Dr. John Quackenbush, PhD, FDA (HTM) (PPT)

Metrology and Standards Needs for Gene Expression Technologies, Krishna Ghosh, Agilent Technologies (HTM) (PPT)

CDER IND/NDA Reviews Guidance, The Common Technical Document and Good Review Practice, Dr. John Leighton, PhD, FDA (HTM) (PPT)

FDA Standards Development and Implementation, Dr. Randy Levin, MD, FDA (HTM) (PPT)

Content, Format, and Standards in Genomics Scale Data, Dr. William Mattes, PhD, Pfizer (HTM) (PPT)

CDER FDA Initiatives, Dr. Lilliam Rosario, PhD, FDA (HTM) (PPT)

The Experimental Design, Dr. John Quackenbush, PhD, FDA (HTM) (PPT)

Questions (HTM) (PPT)