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
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Author: BishopP
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