WASHINGTON, Oct. 28 -- Food and Drug Administration has issued a notice called: Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Oct. 28 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: 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 The draft guidance document provides recommendations for how an individualized human genome editing (GE) product that includes multiple p...