Any biotech company that produces genetically engineered animals for drugs should be prepared to stay in close contact with the FDA. While genetic engineering is common in the food industry, a number of biotechs are also using the science to produce hormones and antibodies that can be used therapeutically. Any snippets of DNA that are introduced into an animal’s genetic code will need to be shared with regulators. And the agency wants to know how any genetic changes could affect an animal’s health.
BIO counts about a dozen companies that are working in the field. And BIO’s Barbara Glenn says the FDA’s action should make investors more confident now that the regulatory process has been clarified. “They know that we will reach commercialization of a product,” Glenn tells the Washington Post.
– read the story from the Washington Post
Singapore researchers support human/animal chimeras
Regulators focusing on transgenic animals (July 2007)