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Home » Delivery Might Be Key to Gene Therapy’s Orphan Status, CBER Official Says
Delivery Might Be Key to Gene Therapy’s Orphan Status, CBER Official Says
The FDA will consider granting orphan status for different gene therapies—even ones in the same class as a previously designated orphan treatment—based on how the therapy is delivered, a high-ranking CBER official said Friday at the Food and Drug Law Institute’s annual meeting in Washington, D.C.