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FDA Announces New Efforts to Advance Biotechnology Innovation

Tuesday, June 12, 2018

(North American Meat Institute)

The Food and Drug Administration (FDA) announced new efforts to advance biotechnology innovation. Specifically, FDA said the recently-established Biotech Working Group will focus efforts on three key areas: advancing and protecting public and animal health by promoting innovation through an efficient and predictable science- and risk-based regulatory framework; strengthening public outreach and communication through strong, effective and transparent engagement with stakeholders; and increasing engagement with domestic and international partners through coordinated and collaborative actions to support regulatory alignment and efficiency.

The Meat Institute previously summarized FDA’s guidance that applies to animals intentionally altered through genome editing techniques. Because gene editing technology would be used in disease prevention practices, the altered genomic DNA in animals meets the definition of a drug outlined in the Food, Drug and Cosmetic Act, and would be regulated as such. The Meat Institute’s comments regarding the regulation of gene-edited animals as animal drugs is available here . The Meat Institute’s comments regarding consumer outreach and education concerning the use of biotechnology in food products can be read here .

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