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Draft Guide on Hemophilia Gene Therapy Products
07/12/2018
 

Federal Register notice: FDA has made available a draft guidance entitled “Human Gene Therapy for Hemophilia; Draft Guidance for Industry.” The document provides recommendations on the clinical trial design and related development of coagulation Factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in the activity assays. The draft guidance also includes recommendations regarding preclinical considerations to support gene therapy development. To view the notice, click here.


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