Re: [DIYbio] Re: "DIY Human CRISPR" by Josiah Zayner

https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm2005904.htm

USFDA

The field of genetics is moving rapidly with new techniques that focus on DNA manipulation in vivo resulting in the alteration of genes to correct mutations, introduce new genetic information, and remove specific DNA sequences. Zinc-Finger Nucleases, TALENs and CRISPR/Cas9 are a few of the genome editing tools that are now available to the scientific research community. To address the societal issues surrounding genome editing, the International Summit on Human Gene Editing, hosted by the scientific academies of China, the United Kingdom and the U.S. was held in December 2015 in Washington DC. The summit concluded that somatic therapies based on genome editing should proceed under the existing FDA regulatory framework, but editing the human germline would be irresponsible to pursue at this time.

FDA has regulatory authority over genetically manipulated cells and/or their derivatives and requires submission of an Investigational New Drug application (IND) before a clinical study can proceed.