Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Friday, February 7, 2020
FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals
The following statement is attributed to FDA Commissioner Stephen M. Hahn, M.D.
“Genome editing is a groundbreaking technology used to introduce intentional genomic alterations in animals and has the potential to improve human and animal health, animal well-being and to enhance food production and quality. It is paramount, however, that as we move forward, we maintain standards of safety and effectiveness.
“This is a tremendously exciting field. Because we’re committed to fostering advances in this space, we take a risk-based approach to oversight. We want to ensure that the intentional genomic alterations in animals are safe for the animal, safe for people eating food products from the animal and that the alteration does what it’s intended to do. That’s why we encourage sponsors to participate in our Veterinary Innovation Program, which facilitates advancements in the development of...