FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products
FDA Finalizes Guidance on Interpretation of Orphan Drug “Sameness” for Gene Therapy Products
By: Rachel Park and Brigid DeCoursey Bondoc
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orp