Gene therapies under the Orphan Drug Regulations to receive drafted guidance for


The CBER of the FDA' s department, specified that due to concurrent analogies or similarities in the product of the gene therapy under the Center for Biologics Evaluation and Research, a guide has been planned to draft which will interpret the "sameness" in the products.

Along with the anticipation on the finalization of other six guidance on gene therapies, which was released last July, this new guidance has attention from all over the world, as this would highlight and instantiate significant remarks in the history of gene therapy. The drafted guidance on the sameness, under the category of Tissues and Advanced Therapies, is expected to be released soon.