Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry; Availability

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availability of a draft document entitled ``Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry.'' The draft guidance provides sponsors, who are developing a human gene therapy (GT) product, recommendations regarding the design of long term follow-up (LTFU) observational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 The draft guidance, when finalized, is intended to supersede the document entitled ``Guidance for Industry: Gene Therapy Clinical Trials--Observing Participants for Delayed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 This draft guidance, when finalized, is also intended to supplement the guidance entitled ``Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus during Product Manufacture and Patient Follow-up; Draft Guidance for Industry.''