Table of Contents
Single Patient Use of Investigational Anticancer Agents:
Rising Public Expectations Make Earlier Access Necessary
Single Patient INDs Provide Needed Access to Promising Experimental Anticancer Compounds:
Initiating the Single Patient IND
Additional Treatment Approaches Are Needed
AstraZeneca Experience ZD1839 (Iressa™)
PPT Slide
Initial Plan: Initiate Phase III Trials
Expanded Access Program (EAP) Previous Precedents
Principles: Iressa Expanded Access Program (EAP)
Registration Is The Best Route To Expanded Access
The Iressa (EAP): Initial Steps
Iressa EAP Protocol
EAP Challenges
EAP Concerns
EAP Opportunities
Implications for the Future
FDA Guidance Needed
Thank You
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