FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: SAFETY ASSESSMENT OF GENOME EDITING IN HUMAN GENE THERAPY PRODUCTS USING NEXT-GENERATION SEQUENCING; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, April 15 -- Food and Drug Administration has issued a notice called: Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on April 15 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document entitled "Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry." The draft document provides recommendations for next-generation sequencing (NGS)-based methods used in nonclinical studi...