U.S. flag An official website of the United States government
  1. Home
  2. Animal & Veterinary
  3. Development & Approval Process
  4. Biotechnology Products at CVM: Animals and Animal Food
  5. Animals with Intentional Genomic Alterations
  1. Development & Approval Process

Animals with Intentional Genomic Alterations

Picture of goats, a chicken, a cow, and pigs

 

On January 19, 2017, the FDA released for public comment draft revised Guidance for Industry (GFI) #187, “Regulation of Intentionally Altered Genomic DNA in Animals.” This draft revised guidance expands the scope of the existing GFI #187 to address animals with intentionally altered genomic DNA developed through use of genome editing technologies, as well as techniques such as rDNA in genetic engineering.

Draft Revised Guidance #187: Regulation of Animals with Intentionally Altered Genomic DNA

Final Guidance #187 Released 1/15/2009

Approvals

Information for Industry

Consumer Health Information

Related Information

Related Information