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The FDA is announcing steps it is taking to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products, to increase regulatory flexibility, predictability and efficiency.
Project aims to generate standardized measurements for characterizing IGAs in cattle and swine that are developed using genome editing.
PhonlamaiPhoto/iStock/Getty Images May 11, 2021 The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) is announcing an Animal Biotechnology Stakeholder Outreach Session that will be open to the public and will take place virtually on Wednesday, July 28 from 3:40 – 4:45 PM ET (2:40 - 3:45p.m. CST) via Zoom. The session is open to all stakeholders at no cost and will take place in conjunction with the Genome Writer’s Guild 2021 conference. At the session, CVM will collect feedback from stakeholders in order to enhance the predictability, tran...
Share this article SILVER SPRING, Md., Feb. 8, 2021 /PRNewswire/ -- The following quote is attributed to Steven M. Solomon, D.V.M., M.P.H., director of the FDA's Center for Veterinary Medicine: Veterinary regenerative medicine is a rapidly growing area of product development that offers great promise in the development of novel therapies for animals. These products, which include animal cell-based therapies such as stem cells, have the potential to repair diseased or damaged tissues in animals through regeneration and healing. Today, the U.S. Food and Drug Administration is announcing a list...
The U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses. The IGA in GalSafe pigs is intended to eliminate alpha-gal sugar on the surface of the pigs’ cells. People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat (e.g., beef, pork, and lamb)...