Policy Statement of the American Society of Gene Therapy on Reporting of Patient Adverse Events in Gene Therapy Trials
Woo, Savio L. C.
Molecular Therapy 2000 January; 1(1): 7-8
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French gene therapy group reports on the adverse event in a clinical trial of gene therapy for X-linked severe combined immune deficiency (X-SCID). Position statement from the European Society of Gene Therapy European Society of Gene Therapy [ESGT] (2003-01)
Guidance for Industry: Gene Therapy Clinical Trials -- Observing Participants for Delayed Adverse Events: Draft Guidance Center for Biologics Evaluation and Research [CBER] (United States) (2005-08)