Table of Contents
Long Term Follow Up of Subjects in Gene Transfer Clinical Trials
September 20, 1993 Letter to Sponsors
Life Long Monitoring: A Key Principle
October 18, 2000 Guidance Document
Current Recommendations Assays
Current Recommendations Testing Schedule
Current Recommendations Testing Schedule (continued)
Current Recommendations Clinical Follow-up
Current Recommendations Clinical Follow-up (continued)
Current Recommendations Documentation
Retroviral Vector Gene Therapy FDA Survey
Retroviral Vector Gene Therapy Long-Term Monitoring Survey
Sponsor’s Comments to FDA Costs
Sponsor’s Comments to FDA Clinical follow-up
Sponsor’s Comments to FDA Commitment
Long-Term Monitoring Survey Autopsies
Long-Term Monitoring Survey Assays/Testing methods
Administrative Actions Assurance of Continued Monitoring
Enforcement Options
Summary
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