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In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.
Since 2017, FDA has approved four gene therapies, and regulators expect the number of gene and cell therapies under development to increase dramatically.
eBook: Regulatory Sourcebook, March 2020
When referring to this article, please cite it as A. Shanley, “Inside FDA’s New Gene and Cell Therapy Guidances," BioPharm International Regulatory Sourcebook eBook (March 2020).