Food and Drug Administration

Oncologic Drugs Advisory Committee

December 5, 2001

Briefing Information

Morning Session

The Development of Diagnostic Immunohistochemistry (IHC) and Fluorescence in situ Hybridization (FISH) Assays Intended to Indentify patients Who Might Benefit from Treatment with a Particular Therapeutic Product [pdf version] [htm version] [Word version]

Bibliography   [pdf version] [htm version] [Word version]

National Surgical Adjuvant Breast and Bowel Project, March 14, 2001, Elizabeth Tan-Chiu, MD  [pdf version]

Preliminary Report: Concordance of Community vs. Central HER2 Testing In the Breast Intergroup Study N9831, Patrick C Roche, PhD, Edith A Perez, MD  [pdf version] [htm version] [Word version]

The NCI Program for the Assessment of Clinical Cancer Tests (PACCT) [pdf version] [htm version] [Word version]