In a recently publishedFDA Voicespiece, Scott Gottlieb and his team had explained how the FDA’s evaluation of plant biotechnology innovations advances the path for producers to bring to the market food products derived from plants produced using biotechnology. This week, the Commissioner, has highlightedthe department’s ongoing implementation of its risk-based regulation of the safety and effectiveness of heritable intentional genomic alterations in animals.

Last October, the FDA announced itsPlant 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.

Scott Gottlieb has said, “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.”

To know more about the statement: https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm634432.htm

This week, the Commissioner, has highlighted the department’s ongoing implementation of its risk-based regulation of the safety and effectiveness of heritable intentional genomic alterations in animals.