Single-Patient Use of Investigational Drugs and Biologic Products for Treating Cancer

2/1/01


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Table of Contents

Single-Patient Use of Investigational Drugs and Biologic Products for Treating Cancer

Objectives

Agenda

Definitions

Cancer Drug Development

Investigational Drug Use

Treatment Use of Investigational Drugs

Treatment Use of Investigational Drugs

Treatment Use of Investigational Drugs

Requirements for Single-Patient Treatment

Evaluating a Request for Treatment Use

When is Single-Patient Use Appropriate?

Author: CDER USER