Long-Term Follow-up of Subjects in Gene Transfer Studies

11/23/01


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Table of Contents

Long-Term Follow-up of Subjects in Gene Transfer Studies

Presentation Outline

Prior BRMAC Discussions

CURRENT FDA LTFU GUIDANCE

BRMAC Meeting November 16-17, 2000

BRMAC Meeting April 5-6, 2001

Proposed 3-Tier System

BRMAC Discussion “Where we left off…”

FDA Working Group

FDA Working Group Considerations

FDA Working Group

FDA Working Group

Malignancy

Malignancy

Malignancy

Malignancy

Malignancy

Hematopoeitic Disorders

Hematopoietic Disorders

Hematopoietic Disorders

Hematopoietic Disorders

Neurologic Disorders

Neurologic Disorders

Neurologic Disorders

Neurologic Disorders

Autoimmune Disorders

Autoimmune Disorders

Autoimmune Disorders

Autoimmune Disorders

Autoimmune Disorders

Summary

Summary

Summary

Author: BishopP