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FDA Announces Plant and Animal Biotechnology Innovation Action Plan

Sunday, November 4, 2018

(North American Meat Institute)

The Food and Drug Administration (FDA) detailed steps the agency will take through 2020 to promote innovation in plant and animal biotechnology applications. The FDA Plant and Animal Biotechnology Innovation Plan will advance FDA policy priorities, clarify the agency's science- and risk-based approach for product developers and eliminate unnecessary barriers to future innovation in plant and animal biotechnology, according to a joint statement released last week from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram. As a first step, FDA will adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including intentionally genetically altered animals and the food and drug products derived from them.

FDA’s action plan identifies three priority areas: advancing human and animal health by promoting product innovation and applying modern, efficient and risk-based regulatory pathways; strengthening public outreach and communication regarding the FDA’s approach to innovative plant and animal biotechnology; and increasing engagement with domestic and international partners on biotechnology issues. Over the next year, FDA will publish two guidance documents explaining how the agency is applying its regulatory oversight to evaluate new animal biotechnology products based on the risk profile of various products.

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