Long Term Follow Up of Subjects in Gene Transfer Clinical Trials

12/5/00


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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

Sponsorís Comments to FDA Costs

Sponsorís Comments to FDA Clinical follow-up

Sponsorís 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

Author: CBER