Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry." The draft guidance provides sponsors, who are developing a human gene therapy (GT) product, recommendations regarding the design of long term follow-up (LTFU) observational studies for the collection of data on delayed adverse events following administration of a GT product. The draft guidance, when finalized, is intended to supersede the document entitled "Guidance for Industry: Gene Therapy Clinical Trials--Observing Participants for Delayed Adverse Events" dated November 2006. This draft guidance, when finalized, is also intended to supplement the guidance entitled "Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus during Product Manufacture and Patient Follow-up; Draft Guidance for Industry."