FDA Law Blog: Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay

FDA Law Blog: Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay

Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay Posted: 05 Sep 2016 07:16 PM PDT Over the course of roughly the last year, gene editing has gone from being a topic limited to scientific conferences to being featured in the New York Times and on the cover of TIME magazine.  Most of the attention has been due to a molecular tool with an opaque name but simple acronym: clustered, regularly interspaced, short palindromic repeat (CRISPR) technology.  Despite all the attention that has come to CRISPR and gene editing in general, many legal questions linger; it is not immediately clear how the FDA and USDA will approach the regulation of various applications of this powerful technology. In the feature article in FDLI’s July/August issue of Update magazine, titled “Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay,” Hyman, Phelps & McNamara, P.C., attorneys Jay W. Cormier and Ricardo Carvajal provide a common understanding about gene editing and CRISPR and discuss potential applications of the technology as well as regulatory issues in the FDA and USDA arenas.