Food and Drug Administration

Oncologic Drugs Advisory Committee

December 16, 2003

Briefing Information

Table of Contents (HTM) (PDF) (Word)

Overview Memorandum (HTM) (PDF) (Word)

Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF)

Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (PDF)

Workshop Summary on Endpoints for Approval of Cancer Drugs for Lung Cancer (HTM) (PDF) (Word)

Guidance for Industry: FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (PDF)

Bibliography (HTM) (PDF) (Word)