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FDA hires staff to streamline biotech animal evaluation amid calls for USDA regulation take over

The FDA has expanded its capacity to handle scientific and risk-based evaluation of biotech animals, the agency’s acting commissioner said [May 2]. The comments, part of Ned Sharpless’ first major public remarks as acting commissioner, come as some livestock interests press for the Agriculture Department to take the lead on gene-edited animals.

The role of FDA’s Center for Veterinary Medicine is to “make sure that the genetic modification is safe to the animal, that it does what it’s supposed to do and that any food-producing animal is safe to eat,” he said during remarks at the Food and Drug Law Institute’s annual conference in Washington.

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“That’s why we have expanded our scientific expertise and hired additional staff to support our science and risk-based evaluation of these products,” Sharpless added. “We encourage developers to interact with us early and on a regular basis as they move these products forward.”

The acting commissioner, who took over for former FDA commissioner Scott Gottlieb in early April, reiterated that the agency is working on additional guidance on the subject. He suggested it would be released later this year.

Read full, original article: FDA adds staff to handle evaluation of biotech animals, new acting chief says (Behind Paywall)

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