The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Long Term Follow-Up After Administration of Human Gene Therapy Products

Origin/Publisher:

FDA Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov,

Document Type:
Draft Guidance
Content:
Recommendations regarding the design of long term follow-up observational studies (LTFU observations) for the collection of data on delayed adverse events following administration of a GT product.

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