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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, transparency, and efficiency of the review process for intentional genomic alterations (IGAs) in animals. Specifically, the Veterinary Innovation Program is available to most developers of IGAs in animals and is aimed at facilitating advancements in the development of innovative animal products by providing greater certainty in the regulatory process, encouraging development and research, and su
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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 listing of clinical field studies that are investigating Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs) in veterinary patients. The webpage provides animal owners, veterinarians, researchers and the public with information on clinical field studies that are being investigated for the use of ACTPs in veterinary patients.
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).
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).