The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management." The draft guidance document provides recommendations for how an individualized human genome editing (GE) product that includes multiple product variants can be submitted in a single Biologics License Application (BLA). When finalized, this guidance will describe the FDA's current thinking on individualized GE products with respect to how to specify the extent of GE component variation in a BLA, how to add new product variants to the BLA after licensure, and related topics.
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