FDA Advancing Beneficial Animal Biotechnology Product Development

Last October, the FDA announced its Plant and Animal Biotechnology Innovation Action Plan, which focuses on the agency’s risk-based regulatory framework. This framework will help secure confidence in the safety and performance of plant and animal-based innovative products for consumers, patients, and America’s global trading partners. Making sure these products are safe and perform as expected is critical to maintaining consumer and commercial confidence in them and realizing their potential benefits for human and animal health. The FDA’s science-based review standards are internationally respected. They provide assurance to global consumers and regulators that animal biotechnology products evaluated by the FDA and exported from the U.S. to other countries are safe and effective. We are taking new steps to advance a framework that allows these products to efficiently secure the FDA’s approval. Our steps are aimed at making sure our approach is tailored to the opportunities enabled by these technologies, and the unique ways in which many genome-altered animals are raised on farms.