Regulatory Services for Genome Editing


Pharmaceutical drugs manufactured using CRISPR-Cas9 technology will have to go thru clinical trial before they can be marketed.

In the U.S. FDA is the regulating agency for clinical trials for pharmaceutical drug products.

FDA protects human health and safety by regulating human and animal drugs, human and animal foods derived from genetically engineered plants, and genetically engineered animals under the authorities of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act (42 U.S.C. ยง201 et seq.).

FDA regulatory requirements apply to all clinical research on pharmaceuticals

Clinical research with CRISPR-Cas9 products requires FDA acceptance of an IND.


If you have any questions or specific project you would like to discuss, please contact our regulatory expert: Hasse Herlevsen - email: