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Human Gene Therapy for Hemophilia

Origin/Publisher:

FDA Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring,

Document Type:
Draft Guidance
Content:
and factor IX activity assays. This guidance also includes recommendations regarding preclinical considerations to support development of GT products for the treatment of hemophilia.

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